Prescription drug · ANDA
Cimetidine NDC 0378-0317
Cimetidine 300 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0317-01 | 0037803170100378031701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0317-01)Marketed from May 17, 1994 |
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
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074246
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0378-0317_e8d57056-b0e8-4d9b-a239-1c3fe27d875eSPL ID e8d57056-b0e8-4d9b-a239-1c3fe27d875eSPL set ID 06c0a509-026f-44e0-9975-a94a8de51d43RxCUI 197505, 197506, 197507, 197508UNII 80061L1WGDUPC 0303780541016, 0303780317017, 0303780053014, 0303780372016
- 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
N400378031701followed by a unit qualifier and the quantityPackage 00378-0317-01. 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 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 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 cimetidine …
Excerpt only. Read the full label for complete information.
About NDC 0378-0317
- What is NDC 0378-0317?
- 0378-0317 is the product NDC for Cimetidine, Cimetidine 300 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cimetidine.
- What is the active ingredient?
- Cimetidine.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cimetidine?
- 21 other product NDCs are listed under this name. See all Cimetidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cimetidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cimetidine | Cimetidine 200 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-323 | 69452-0323-2069452-0323-30 |
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-324 | 69452-0324-2069452-0324-30 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-325 | 69452-0325-2069452-0325-30 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-326 | 69452-0326-2069452-0326-30 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-825 | 59651-0825-0159651-0825-05 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-826 | 59651-0826-01 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-697 | 51655-0697-51 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0500 | 50090-0500-0050090-0500-01 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-333 | 63187-0333-30 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8305 | 00093-8305-01 |
Other NDCs under ANDA 074246
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 | Mylan Pharmaceuticals Inc. | 0378-0053 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0372 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0541 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3574 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-697 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-581 |