Prescription drug · ANDA
Famotidine NDC 82804-980
Famotidine 20 mg/1 · Tablet, Coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-980-00 | 82804098000 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-00)Marketed from Jan 27, 2025 | |
| 82804-980-20 | 82804098020 | 20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-20)Marketed from Jan 27, 2025 | |
| 82804-980-30 | 82804098030 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-30)Marketed from Jan 27, 2025 | |
| 82804-980-55 | 82804098055 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-55)Marketed from Jan 27, 2025 | |
| 82804-980-60 | 82804098060 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-60)Marketed from Jan 27, 2025 | |
| 82804-980-67 | 82804098067 | 270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-67)Marketed from Jan 27, 2025 | |
| 82804-980-72 | 82804098072 | 120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-72)Marketed from Jan 27, 2025 | |
| 82804-980-78 | 82804098078 | 180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-78)Marketed from Jan 27, 2025 | |
| 82804-980-90 | 82804098090 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-90)Marketed from Jan 27, 2025 |
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 — 20 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217669
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 82804-980_7335a9b3-33fb-4343-bc31-b26dd58c0a1cSPL ID 7335a9b3-33fb-4343-bc31-b26dd58c0a1cSPL set ID c7327748-835b-44df-848f-8c620d327ce6RxCUI 284245, 310273UNII 5QZO15J2Z8UPC 0382804981205, 0382804980208
- 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
N482804098000followed by a unit qualifier and the quantityPackage 82804-0980-00. 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 greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive 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 gastr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217669
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 | Tablet, CoatedOral | Proficient Rx LP | 82804-981 |
| Famotidine | Famotidine 20 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-400 |
| Famotidine | Famotidine 40 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-401 |
| Famotidine | Famotidine 20 mg/1 | Tablet, CoatedOral | Contract Pharmacal Corp. | 10267-5689 |
| Famotidine | Famotidine 40 mg/1 | Tablet, CoatedOral | Contract Pharmacal Corp. | 10267-5690 |
| Famotidine | Famotidine 40 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-228 |
| Famotidine | Famotidine 20 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4088 |