Over-the-counter drug · ANDA
Cetirizine HCl (Cetirizine) NDC 72657-129
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · GLENMARK THERAPEUTICS INC., USA
NDC codes
FDA NDC DirectoryProduct NDC (as listed)72657-129Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72657-0129Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72657-129-03 | 7265701290372657012903 | 1 BOTTLE in 1 CARTON (72657-129-03) / 300 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-04 | 7265701290472657012904 | 1 BOTTLE in 1 CARTON (72657-129-04) / 400 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-08 | 7265701290872657012908 | 1 BOTTLE in 1 CARTON (72657-129-08) / 120 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-14 | 7265701291472657012914 | 1 BOTTLE in 1 CARTON (72657-129-14) / 140 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-15 | 7265701291572657012915 | 1 BOTTLE in 1 CARTON (72657-129-15) / 150 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-18 | 7265701291872657012918 | 1 BOTTLE in 1 CARTON (72657-129-18) / 180 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-24 | 7265701292472657012924 | 1 BOTTLE in 1 CARTON (72657-129-24) / 240 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-30 | 7265701293072657012930 | 1 BOTTLE in 1 CARTON (72657-129-30) / 30 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-35 | 7265701293572657012935 | 1 BOTTLE in 1 CARTON (72657-129-35) / 365 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-41 | 7265701294172657012941 | 1 BOTTLE in 1 CARTON (72657-129-41) / 14 TABLET in 1 BOTTLEMarketed from Apr 3, 2025 | |
| 72657-129-45 | 7265701294572657012945 | 1 BOTTLE in 1 CARTON (72657-129-45) / 45 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-60 | 7265701296072657012960 | 1 BOTTLE in 1 CARTON (72657-129-60) / 60 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-70 | 7265701297072657012970 | 1 BOTTLE in 1 CARTON (72657-129-70) / 70 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-81 | 7265701298172657012981 | 2 BOTTLE in 1 CARTON (72657-129-81) / 60 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-82 | 7265701298272657012982 | 2 BOTTLE in 1 CARTON (72657-129-82) / 70 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-84 | 7265701298472657012984 | 2 BOTTLE in 1 CARTON (72657-129-84) / 90 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-86 | 7265701298672657012986 | 2 BOTTLE in 1 CARTON (72657-129-86) / 120 TABLET in 1 BOTTLEMarketed from May 13, 2024 | |
| 72657-129-90 | 7265701299072657012990 | 1 BOTTLE in 1 CARTON (72657-129-90) / 90 TABLET in 1 BOTTLEMarketed from May 13, 2024 |
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 HCl
- Generic name (nonproprietary)
- cetirizine
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GLENMARK THERAPEUTICS INC., USANDC labeler code 72657
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078427
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72657-129_42c1f2da-97b4-4583-bf62-368be53900c2SPL ID 42c1f2da-97b4-4583-bf62-368be53900c2SPL set ID 04b08c52-5390-4cdb-a9e7-fca81fffdc73RxCUI 1014676, 1014678UNII 64O047KTOAUPC 0372657129350
- 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
N472657012903followed by a unit qualifier and the quantityPackage 72657-0129-03. 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 72657-129
- What is NDC 72657-129?
- 72657-129 is the product NDC for Cetirizine HCl (cetirizine), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by GLENMARK THERAPEUTICS INC., USA. It has 18 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine HCl (Cetirizine).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- GLENMARK THERAPEUTICS INC., USA, NDC labeler code 72657. 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 HCl?
- 24 other product NDCs are listed under this name. See all Cetirizine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine HCl 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 HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS Pharmacy | 51316-900 | 51316-0900-19 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | PUBLIX SUPER MARKETS INC | 56062-495 | 56062-0495-86 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | TOP CARE (Topco Associates LLC) | 36800-543 | 36800-0543-1536800-0543-86 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | AMERISOURCE BERGEN | 46122-815 | 46122-0815-64 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | WALGREEN COMPANY | 0363-6341 | 00363-6341-1500363-6341-78 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | KROGER COMPANY | 59450-020 | 59450-0020-1559450-0020-86 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-479 | 69452-0479-88 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Meijer Distribution Inc | 79481-0671 | 79481-0671-02 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | TARGET Corporation | 11673-650 | 11673-0650-15 |
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | GERI-CARE PHARMACEUTICAL CORP | 57896-992 | 57896-0992-01 |
Other NDCs under ANDA 078427
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 |
|---|---|---|---|---|
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1279 |
| Cetirizine HClcetirizine | Cetirizine hydrochloride 5 mg/1 | TabletOral | GLENMARK THERAPEUTICS INC., USA | 72657-128 |
| Cetirizine HClcetirizine | — | Kit | GLENMARK THERAPEUTICS INC., USA | 72657-130 |
| Cetirizine HClcetirizine | — | Kit | GLENMARK THERAPEUTICS INC., USA | 72657-131 |