Prescription drug · ANDA
Famotidine NDC 43063-696
Famotidine 40 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-696-30 | 43063069630 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-696-30)Marketed from Jul 26, 2016 | |
| 43063-696-90 | 43063069690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-696-90)Marketed from Jul 26, 2016 | |
| 43063-696-93 | 43063069693 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-696-93)Marketed from Jul 26, 2016 | |
| 43063-696-95 | 43063069695 | 1000 TABLET in 1 BOTTLE, PLASTIC (43063-696-95)Marketed from May 11, 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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075805
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43063-696_4147b115-910a-13aa-e063-6394a90ad9e9SPL ID 4147b115-910a-13aa-e063-6394a90ad9e9SPL set ID 09ef39a4-c6b3-4395-8211-3f551dc44830RxCUI 284245UNII 5QZO15J2Z8UPC 0343063696958
- 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
N443063069630followed by a unit qualifier and the quantityPackage 43063-0696-30. 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)
Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer(GU). • symptomatic non-erosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated (1): In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075805
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 |
|---|---|---|---|---|
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1737 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4197 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2014 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2015 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | AvPAK | 50268-304 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Proficient Rx LP | 63187-129 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Proficient Rx LP | 71205-257 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2782 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-036 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-683 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-684 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Carlsbad Technology, Inc | 61442-121 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Carlsbad Technology, Inc | 61442-122 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-7966 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-470 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1520 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2306 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-1045 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | direct rx | 72189-207 |
| Pepcidfamotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Bausch Health US LLC | 0187-4420 |
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