Over-the-counter drug · ANDA
Famotidine NDC 0363-5300
Famotidine 20 mg/1 · Tablet, Film coated · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-5300-14 | 00363530014 | 1 BOTTLE in 1 CARTON (0363-5300-14) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 26, 2016 | |
| 0363-5300-34 | 00363530034 | 1 BOTTLE in 1 CARTON (0363-5300-34) / 200 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 26, 2022 | |
| 0363-5300-47 | 00363530047 | 1 BOTTLE in 1 CARTON (0363-5300-47) / 75 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 17, 2024 | |
| 0363-5300-50 | 00363530050 | 1 BOTTLE in 1 CARTON (0363-5300-50) / 85 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 26, 2016 | |
| 0363-5300-53 | 00363530053 | 1 BOTTLE in 1 CARTON (0363-5300-53) / 25 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 26, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
- Route
- Oral
- Labeler
- WALGREEN CO.NDC labeler code 0363
- 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 0363-5300_d8272405-523e-4572-ac4c-721ef990cf51SPL ID d8272405-523e-4572-ac4c-721ef990cf51SPL set ID 2766ffe7-2f1c-48c8-8f67-0a2819dcc3beRxCUI 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
N400363530014followed by a unit qualifier and the quantityPackage 00363-5300-14. 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 0363-5300
- What is NDC 0363-5300?
- 0363-5300 is the product NDC for Famotidine, Famotidine 20 mg/1 tablet, film coated, listed with the FDA by WALGREEN CO.. It has 5 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?
- WALGREEN CO., NDC labeler code 0363. 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 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 10 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-828 |
| 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 |
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