Prescription drug · ANDA
Famotidine NDC 53401-036
Famotidine 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53401-036Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53401-0036Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-036-53 | 5340100365353401003653 | 60 TABLET in 1 BOTTLE (53401-036-53)Marketed from Sep 14, 2026 | |
| 53401-036-60 | 5340100366053401003660 | 90 TABLET in 1 BOTTLE (53401-036-60)Marketed from Sep 14, 2026 |
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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- 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 53401-036_5b9c6ef9-77f6-4251-e063-6394a90ad362SPL ID 5b9c6ef9-77f6-4251-e063-6394a90ad362
- 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
N453401003653followed by a unit qualifier and the quantityPackage 53401-0036-53. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 53401-036
- What is NDC 53401-036?
- 53401-036 is the product NDC for Famotidine, Famotidine 40 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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 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 | NuCare Pharmaceuticals,Inc. | 68071-4197 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Proficient Rx LP | 71205-257 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1520 |
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