Over-the-counter drug · ANDA
Cetirizine Hydrochloride (Allergy) (Cetirizine hydrochloride) NDC 58602-445
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Aurohealth LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58602-445Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0445Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-445-01 | 5860204450158602044501 | 1 BLISTER PACK in 1 CARTON (58602-445-01) / 14 TABLET in 1 BLISTER PACKMarketed from Aug 5, 2015 | |
| 58602-445-09 | 5860204450958602044509 | 1 BOTTLE in 1 CARTON (58602-445-09) / 30 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-15 | 5860204451558602044515 | 1 BOTTLE in 1 CARTON (58602-445-15) / 60 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-17 | 5860204451758602044517 | 1 BOTTLE in 1 CARTON (58602-445-17) / 45 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-19 | 5860204451958602044519 | 1 BOTTLE in 1 CARTON (58602-445-19) / 90 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-21 | 5860204452158602044521 | 10 BLISTER PACK in 1 CARTON (58602-445-21) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 5, 2015 | |
| 58602-445-23 | 5860204452358602044523 | 1 BOTTLE in 1 CARTON (58602-445-23) / 120 TABLET in 1 BOTTLEMarketed from Aug 6, 2026 | |
| 58602-445-38 | 5860204453858602044538 | 1 BOTTLE in 1 CARTON (58602-445-38) / 300 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-39 | 5860204453958602044539 | 1 BOTTLE in 1 CARTON (58602-445-39) / 365 TABLET in 1 BOTTLEMarketed from Aug 6, 2026 | |
| 58602-445-40 | 5860204454058602044540 | 500 TABLET in 1 BOTTLE (58602-445-40)Marketed from Aug 5, 2015 | |
| 58602-445-41 | 5860204454158602044541 | 1000 TABLET in 1 BOTTLE (58602-445-41)Marketed from Aug 5, 2015 | |
| 58602-445-47 | 5860204454758602044547 | 75 TABLET in 1 PACKAGE, COMBINATION (58602-445-47)Marketed from Aug 5, 2015 | |
| 58602-445-54 | 5860204455458602044554 | 1 BOTTLE in 1 CARTON (58602-445-54) / 70 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-445-60 | 5860204456058602044560 | 1 BLISTER PACK in 1 CARTON (58602-445-60) / 5 TABLET in 1 BLISTER PACKMarketed from Aug 5, 2015 | |
| 58602-445-65 | 5860204456558602044565 | 2 BLISTER PACK in 1 CARTON (58602-445-65) / 7 TABLET in 1 BLISTER PACKMarketed from Nov 21, 2019 | |
| 58602-445-94 | 5860204459458602044594 | 1 BOTTLE in 1 CARTON (58602-445-94) / 100 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cetirizine Hydrochloride (Allergy)
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090760
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-445_09cf1596-6539-44ff-9f90-a0fb1f218b4eSPL ID 09cf1596-6539-44ff-9f90-a0fb1f218b4eSPL set ID 3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25RxCUI 1014676, 1014678UNII 64O047KTOA
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458602044501followed by a unit qualifier and the quantityPackage 58602-0445-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 58602-445
- What is NDC 58602-445?
- 58602-445 is the product NDC for Cetirizine Hydrochloride (Allergy), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Aurohealth LLC. It has 16 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride (Allergy) (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetirizine Hydrochloride (Allergy)?
- 22 other product NDCs are listed under this name. See all Cetirizine Hydrochloride (Allergy) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine Hydrochloride (Allergy) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | INNOVUS PHARMACEUTICALS, INC. | 57483-190 | 57483-0190-14 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Better Living Brands, LLC | 21130-099 | 21130-0099-97 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Better Living Brands, LLC | 21130-098 | 21130-0098-23 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-861 | 58602-0861-40 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-716 | 58602-0716-16 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | RITE AID CORPORATION | 11822-4228 | 11822-4228-0111822-4228-02 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8204 | 68788-8204-0068788-8204-0168788-8204-03+3 more |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREEN CO. | 0363-9602 | 00363-9602-09 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | KROGER COMPANY | 30142-172 | 30142-0172-0930142-0172-54 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-863 | 58602-0863-12 |
Other NDCs under ANDA 090760
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amazon Basic Care All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-691 |
| Cetirizine Hydrochloridecetirizine hydrochloride allergy | Cetirizine hydrochloride 10 mg/1 | TabletOral | LEADER/ CARDINAL HEALTH 110, INC. | 70000-0047 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREEN CO. | 0363-9602 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | NorthStar Rx LLC | 16714-799 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Better Living Brands, LLC | 21130-098 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | KROGER COMPANY | 30142-172 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6168 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6170 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6950 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | INNOVUS PHARMACEUTICALS, INC. | 57483-190 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Aurohealth LLC | 58602-444 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-812 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-823 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-861 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BluePoint Laboratories | 68001-436 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8204 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-237 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-700 |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Aurohealth LLC | 58602-446 |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-447 |
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