Prescription drug · ANDA
Cimetidine NDC 69452-324
Cimetidine 300 mg/1 · Tablet, Film coated · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-324-20 | 69452032420 | 100 TABLET, FILM COATED in 1 BOTTLE (69452-324-20)Marketed from Mar 1, 2025 | |
| 69452-324-30 | 69452032430 | 500 TABLET, FILM COATED in 1 BOTTLE (69452-324-30)Marketed from Mar 1, 2025 |
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)
- Cimetidine
- Generic name (nonproprietary)
- cimetidine
- Active ingredients
- Cimetidine — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bionpharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218220
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69452-324_2d7b7608-a2bd-dfde-e063-6294a90afa2cSPL ID 2d7b7608-a2bd-dfde-e063-6294a90afa2cSPL set ID 2d7b6e7d-cf01-70a2-e063-6394a90afbe6RxCUI 197505, 197506, 197507, 197508UNII 80061L1WGD
- Pharmacologic class
- Histamine-2 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
N469452032420followed by a unit qualifier and the quantityPackage 69452-0324-20. 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)
INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 weeks to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimet…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218220
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 |
|---|---|---|---|---|
| Cimetidine | Cimetidine 200 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-323 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-325 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-326 |