Over-the-counter drug · ANDA
Famotidine 10 mg NDC 25000-086
Famotidine 10 mg/1 · Tablet, Coated · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-086-03 | 25000008603 | 1 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLEMarketed from Mar 10, 2023 | |
| 25000-086-07 | 25000008607 | 1 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLEMarketed from Apr 24, 2024 | |
| 25000-086-08 | 25000008608 | 1 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLEMarketed from Mar 10, 2023 | |
| 25000-086-36 | 25000008636 | 3 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Mar 10, 2023 |
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 10 mg
- Generic name (nonproprietary)
- famotidine 10 mg
- Active ingredients
- Famotidine — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITED
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217543
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402SPL ID c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402SPL set ID 58b653eb-6539-4b79-9d22-df6eaf35307fRxCUI 199047, 310273UNII 5QZO15J2Z8UPC 0325000086039, 0325000087364, 0325000086367, 0325000086084, 0325000087081, 0325000087036, 0325000087821
- 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
N425000008603followed by a unit qualifier and the quantityPackage 25000-0086-03. 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 217543
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 |
|---|---|---|---|---|
| Original strength heartburn preventionfamotidine | Famotidine 10 mg/1 | TabletOral | KROGER COMPANY | 41226-719 |
| Maximum Strength Acid Reducerfamotidine | Famotidine 20 mg/1 | TabletOral | TARGET CORPORATION | 11673-697 |
| Maximum Strength Acid Reducerfamotidine | Famotidine 20 mg/1 | TabletOral | TIME CAP LABORATORIES,INC | 49483-720 |
| Maximum Strength Acid Controllerfamotidine | Famotidine 20 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-027 |
| Famotidine 20 mg | Famotidine 20 mg/1 | Tablet, CoatedOral | MARKSANS PHARMA LIMITED | 25000-087 |
| Famotidine 20 mg | Famotidine 20 mg/1 | Tablet, CoatedOral | MARKSANS PHARMA LIMITED | 25000-124 |