Over-the-counter drug · ANDA
Famotidine NDC 58602-828
Famotidine 10 mg/1 · Tablet, Film coated · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-828-19 | 58602082819 | 1 BOTTLE in 1 CARTON (58602-828-19) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 26, 2016 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206531
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-828_01351d50-0222-4f6c-93cc-66b2afb98669SPL ID 01351d50-0222-4f6c-93cc-66b2afb98669SPL set ID 27ecf5c1-202a-44cf-94f9-d7fefa027e1eRxCUI 199047UNII 5QZO15J2Z8UPC 0358602828196
- 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
N458602082819followed by a unit qualifier and the quantityPackage 58602-0828-19. 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 58602-828
- What is NDC 58602-828?
- 58602-828 is the product NDC for Famotidine, Famotidine 10 mg/1 tablet, film coated, listed with the FDA by Aurohealth LLC. 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?
- Aurohealth LLC, NDC labeler code 58602. 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?
- 254 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 206531
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 |
|---|---|---|---|---|
| Amazon Basic Care Acid Reducerfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-363 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | WALGREEN CO. | 0363-1899 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | WALGREEN CO. | 0363-4400 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | WALGREEN CO. | 0363-5300 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | WALGREEN CO. | 0363-9607 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-033 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Better Living Brands LLC | 21130-039 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-735 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-737 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores, Inc. | 49035-505 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores, Inc. | 49035-589 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Magno-Humphries, Inc. | 54257-180 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Magno-Humphries, Inc. | 54257-802 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Fred's, Inc. | 55315-435 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Family Dollar Stores, LLC | 55319-057 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-705 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-706 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-829 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-859 |
| Famotidine | Famotidine 10 mg/1 | Tablet, Film coatedOral | Best Choice | 63941-009 |
Showing 20 of 39.