Over-the-counter drug · ANDA
Cetirizine Hydrochloride (Allergy) (Cetirizine hydrochloride) NDC 58602-806
Cetirizine hydrochloride 10 mg/1 · Capsule · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-806-04 | 5860208060458602080604 | 1 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLEMarketed from Jul 20, 2018 | |
| 58602-806-12 | 5860208061258602080612 | 1 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLEMarketed from Jul 20, 2018 | |
| 58602-806-16 | 5860208061658602080616 | 65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLEMarketed from Jul 20, 2018 | |
| 58602-806-53 | 5860208065358602080653 | 1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLEMarketed from Jul 20, 2018 |
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
- Capsule
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209107
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-806_a74bd49f-8718-4483-9019-b761138669c9SPL ID a74bd49f-8718-4483-9019-b761138669c9SPL set ID ffbca2a4-8df0-4c85-adf9-9414cd706fb2RxCUI 1014675UNII 64O047KTOAUPC 0358602806040
- 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
N458602080604followed by a unit qualifier and the quantityPackage 58602-0806-04. 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 58602-806
- What is NDC 58602-806?
- 58602-806 is the product NDC for Cetirizine Hydrochloride (Allergy), Cetirizine hydrochloride 10 mg/1 capsule, listed with the FDA by Aurohealth LLC. It has 4 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 209107
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 Basics All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Amazon.com Services LLC | 72288-013 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | WALGREEN CO. | 0363-0068 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | RITE AID CORPORATION | 11822-4228 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Better Living Brands, LLC | 21130-099 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-716 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-863 |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-808 |