Prescription drug · ANDA
Famotidine NDC 82804-194
Famotidine 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-194-06 | 8280401940682804019406 | 6 TABLET, FILM COATED in 1 BOTTLE (82804-194-06)Marketed from Jun 1, 2026 | |
| 82804-194-10 | 8280401941082804019410 | 10 TABLET, FILM COATED in 1 BOTTLE (82804-194-10)Marketed from May 28, 2025 | |
| 82804-194-30 | 8280401943082804019430 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-194-30)Marketed from Apr 25, 2025 | |
| 82804-194-60 | 8280401946082804019460 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-194-60)Marketed from Apr 23, 2026 | |
| 82804-194-78 | 8280401947882804019478 | 180 TABLET, FILM COATED in 1 BOTTLE (82804-194-78)Marketed from Jun 5, 2025 | |
| 82804-194-90 | 8280401949082804019490 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-194-90)Marketed from Feb 4, 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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075718
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 82804-194_6df62699-a835-40d3-b22b-2e4db6f4bf3cSPL ID 6df62699-a835-40d3-b22b-2e4db6f4bf3cSPL set ID 68d21d95-9603-4e68-855a-bfc65b1b58c3RxCUI 310273UNII 5QZO15J2Z8UPC 0382804194902
- 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
N482804019406followed by a unit qualifier and the quantityPackage 82804-0194-06. 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 ( Error! Hyperlink reference not valid. ): In adult and pediatric patients 40 kg and greater for the treatment of: • active…
Excerpt only. Read the full label for complete information.
About NDC 82804-194
- What is NDC 82804-194?
- 82804-194 is the product NDC for Famotidine, Famotidine 20 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 6 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?
- Proficient Rx LP, NDC labeler code 82804. 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?
- 252 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 075718
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 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7193 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-299 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-119 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-120 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2628 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4313 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-594 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8889 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1950 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-543 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-091 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-221 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-222 |