Over-the-counter drug · ANDA
TopCare Acid Reducer (Famotidine) NDC 36800-141
Famotidine 10 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-141-65 | 3680001416536800014165 | 30 BLISTER PACK in 1 CARTON (36800-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 13, 2009 | |
| 36800-141-72 | 3680001417236800014172 | 1 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 11, 2009 | |
| 36800-141-75 | 3680001417536800014175 | 1 BOTTLE in 1 CARTON (36800-141-75) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 22, 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)
- TopCare Acid Reducer
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075400
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-141_c15b21b3-6e50-4ed4-90ef-28483e1cf535SPL ID c15b21b3-6e50-4ed4-90ef-28483e1cf535SPL set ID 88722f84-dac8-4130-93b3-9e0dc1cc5accRxCUI 199047UNII 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
N436800014165followed by a unit qualifier and the quantityPackage 36800-0141-65. 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 36800-141
- What is NDC 36800-141?
- 36800-141 is the product NDC for TopCare Acid Reducer (famotidine), Famotidine 10 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Acid Reducer (Famotidine).
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare Acid Reducer?
- 2 other product NDCs are listed under this name. See all TopCare Acid Reducer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TopCare Acid Reducer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| topcare acid reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 76162-300 | 76162-0300-71 |
| TopCare Acid Reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-194 | 36800-0194-0236800-0194-7136800-0194-78 |
Other NDCs under ANDA 075400
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 Controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-771 |
| acid controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | H E B | 37808-301 |
| Acid Controller Original Strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0141 |
| acid controller original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-141 |
| Acid Reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-816 |
| acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-141 |
| Acid Reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-756 |
| acid reducer original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-141 |
| basic care acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-141 |
| CareOne Acid Relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-901 |
| dg health heartburn prevention original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-141 |
| equaline heartburn preventionfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-313 |
| Equate Famotidinefamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-507 |
| foster and thrive acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1102 |
| good sense acid reducerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0141 |
| heartburn relieffamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-493 |
| heartburn relief original strengthfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5529 |
| heartburn relief original strengthfamotidine | Famotidine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-999 |
| signature care acid controllerfamotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-249 |