Prescription drug · ANDA
Famotidine NDC 68071-4197
Famotidine 40 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4197-3 | 6807141970368071419703 | 30 TABLET in 1 BOTTLE (68071-4197-3)Marketed from Dec 20, 2017 | |
| 68071-4197-6 | 6807141970668071419706 | 60 TABLET in 1 BOTTLE (68071-4197-6)Marketed from Dec 20, 2017 | |
| 68071-4197-9 | 6807141970968071419709 | 90 TABLET in 1 BOTTLE (68071-4197-9)Marketed from Dec 20, 2017 |
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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075805
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470SPL ID 1a3b98e7-ec70-569d-e063-6394a90a4470SPL set ID 60cd0973-f74e-2b70-e053-2a91aa0a4361RxCUI 284245UNII 5QZO15J2Z8UPC 0368071419733
- 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
N468071419703followed by a unit qualifier and the quantityPackage 68071-4197-03. 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)
INDICATIONS AND USAGE Famotidine is indicated in: Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active ben…
Excerpt only. Read the full label for complete information.
About NDC 68071-4197
- What is NDC 68071-4197?
- 68071-4197 is the product NDC for Famotidine, Famotidine 40 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Famotidine.
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Famotidine?
- 252 other product NDCs are listed under this name. See all Famotidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Famotidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Famotidine | Famotidine 40 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 72603-564 | 72603-0564-01 |
| Famotidine | Famotidine 40 mg/5mL | Powder, For suspensionOral | RISING PHARMA HOLDINGS, INC. | 64980-737 | 64980-0737-50 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4144 | 68788-4144-0368788-4144-0468788-4144-06+1 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0589 | 80425-0589-0180425-0589-0280425-0589-03 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Family Dollar Stores, LLC | 55319-057 | 55319-0057-1055319-0057-2555319-0057-50 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-030 | 87441-0030-01 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4119 | 68788-4119-0168788-4119-0368788-4119-04+3 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-150 | 48433-0150-20 |
| Famotidine | Famotidine 20 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4088 | 68788-4088-0368788-4088-0468788-4088-06+1 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4574 | 70518-4574-0070518-4574-0170518-4574-02+1 more |
Other NDCs under ANDA 075805
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 |
|---|---|---|---|---|
| Famotidine | Famotidine 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-695 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-696 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-1045 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-1432 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-7966 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | AvPAK | 50268-304 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-683 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-684 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-312 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-036 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Carlsbad Technology, Inc | 61442-121 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Carlsbad Technology, Inc | 61442-122 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Proficient Rx LP | 63187-129 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2014 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2015 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2782 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7013 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2306 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Proficient Rx LP | 71205-257 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1520 |
Showing 20 of 25.