Over-the-counter drug · ANDA
Cetirizine Hydrochloride (Allergy) (Cetirizine hydrochloride) NDC 68788-8204
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-8204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8204Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8204-0 | 6878882040068788820400 | 100 TABLET in 1 BOTTLE (68788-8204-0)Marketed from Apr 1, 2022 | |
| 68788-8204-1 | 6878882040168788820401 | 14 TABLET in 1 BOTTLE (68788-8204-1)Marketed from Apr 1, 2022 | |
| 68788-8204-3 | 6878882040368788820403 | 30 TABLET in 1 BOTTLE (68788-8204-3)Marketed from Apr 1, 2022 | |
| 68788-8204-5 | 6878882040568788820405 | 15 TABLET in 1 BOTTLE (68788-8204-5)Marketed from Apr 1, 2022 | |
| 68788-8204-6 | 6878882040668788820406 | 60 TABLET in 1 BOTTLE (68788-8204-6)Marketed from Apr 1, 2022 | |
| 68788-8204-9 | 6878882040968788820409 | 90 TABLET in 1 BOTTLE (68788-8204-9)Marketed from Apr 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-8204_ec89e868-59e4-4bbd-8c95-5cf56f7df9ceSPL ID ec89e868-59e4-4bbd-8c95-5cf56f7df9ceSPL set ID 73122009-531b-4929-bf57-494a6fc65b73RxCUI 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
N468788820400followed by a unit qualifier and the quantityPackage 68788-8204-00. 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 68788-8204
- What is NDC 68788-8204?
- 68788-8204 is the product NDC for Cetirizine Hydrochloride (Allergy), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 | 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 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BluePoint Laboratories | 68001-436 | 68001-0436-0468001-0436-9668001-0436-97 |
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 | 58602-445 |
| 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 | 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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