Prescription drug · ANDA
Cimetidine NDC 0093-8192
Cimetidine 300 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-8192-01 | 00093819201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)Marketed from Nov 24, 2003 | |
| 0093-8192-05 | 00093819205 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)Marketed from Jan 28, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074151
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0093-8192_e1f40596-aa5b-46a4-b2aa-add1150ac3a1SPL ID e1f40596-aa5b-46a4-b2aa-add1150ac3a1SPL set ID 496e258d-a5fd-42da-9a86-73afc8be359bRxCUI 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
N400093819201followed by a unit qualifier and the quantityPackage 00093-8192-01. 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)
INDICATIONS AND USAGE Cimetidine tablets USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION , Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074151
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 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0500 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-333 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8204 |
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1783 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.