Over-the-counter drug · ANDA
Famotidine NDC 63868-583
Famotidine 10 mg/1 · Tablet · Oral · Chain Drug Marketing Association INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-583-30 | 63868058330 | 1 BOTTLE in 1 CARTON (63868-583-30) / 30 TABLET in 1 BOTTLEMarketed from Dec 1, 2020 |
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
- Route
- Oral
- 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 63868-583_cf8df4a2-be86-9900-a859-a08b841f6a53SPL ID cf8df4a2-be86-9900-a859-a08b841f6a53SPL set ID 1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0aRxCUI 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
N463868058330followed by a unit qualifier and the quantityPackage 63868-0583-30. 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.
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 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Dr.Reddys Laboratories Limited | 55111-118 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Albertsons Companies | 21130-022 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Albertsons Companies | 21130-023 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Discount Drug Mart, Inc | 53943-101 |
| Famotidine | Famotidine 10 mg/1 | TabletOral | Discount Drug Mart, Inc | 53943-100 |
| 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 | Dr.Reddys Laboratories Limited | 55111-396 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Chain Drug Marketing Association INC | 63868-584 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Chain Drug Marketing Association INC | 83324-116 |
| 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 | 83324-139 |
| Acid Reducer Original Strengthfamotidine | Famotidine 10 mg/1 | TabletOral | Dr.Reddys Laboratories Inc. | 43598-824 |