Over-the-counter drug · ANDA
Famotidine NDC 53943-101
Famotidine 20 mg/1 · Tablet · Oral · Discount Drug Mart, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-101-25 | 5394301012553943010125 | 1 BOTTLE in 1 CARTON (53943-101-25) / 25 TABLET in 1 BOTTLEMarketed from Jan 1, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Discount Drug Mart, IncNDC labeler code 53943
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077367
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53943-101_a9ec4a5f-1e94-74d2-5fa5-7f032c87e11bSPL ID a9ec4a5f-1e94-74d2-5fa5-7f032c87e11bSPL set ID c5d81352-c45b-3ea1-9974-8a096bd05009RxCUI 199047, 310273UNII 5QZO15J2Z8
- 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
N453943010125followed by a unit qualifier and the quantityPackage 53943-0101-25. 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)
Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Excerpt only. Read the full label for complete information.
About NDC 53943-101
- What is NDC 53943-101?
- 53943-101 is the product NDC for Famotidine, Famotidine 20 mg/1 tablet, listed with the FDA by Discount Drug Mart, Inc. It has 1 package NDC, 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?
- Discount Drug Mart, Inc, NDC labeler code 53943. 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 077367
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 |
|---|---|---|---|---|
| Acid Reducer Maximum Strengthfamotidine | Famotidine 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc. | 43598-960 |
| Acid Reducer Original Strengthfamotidine | Famotidine 10 mg/1 | TabletOral | Dr.Reddys Laboratories Inc. | 43598-824 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Albertsons Companies | 21130-022 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Albertsons Companies | 21130-023 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Discount Drug Mart, Inc | 53943-100 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Dr.Reddys Laboratories Limited | 55111-118 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Family Dollar Stores, Inc. | 55319-426 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Family Dollar Stores, Inc. | 55319-427 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Chain Drug Marketing Association INC | 63868-583 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Chain Drug Marketing Association INC | 63868-584 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Chain Drug Consortium, LLC | 68016-800 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Chain Drug Consortium, LLC | 68016-801 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Chain Drug Marketing Association INC | 83324-116 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Chain Drug Marketing Association INC | 83324-139 |