Prescription drug · ANDA
Famotidine NDC 68788-8733
Famotidine 40 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8733-3 | 6878887330368788873303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8733-3)Marketed from Sep 16, 2024 | |
| 68788-8733-4 | 6878887330468788873304 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8733-4)Marketed from Sep 16, 2024 | |
| 68788-8733-6 | 6878887330668788873306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8733-6)Marketed from Sep 16, 2024 | |
| 68788-8733-9 | 6878887330968788873309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8733-9)Marketed from Sep 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215767
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8733_9f00fdc6-548c-4d4e-ab25-d9196495f364SPL ID 9f00fdc6-548c-4d4e-ab25-d9196495f364SPL set ID b1edf3c5-e42c-471b-8771-6c93094822deRxCUI 284245UNII 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
N468788873303followed by a unit qualifier and the quantityPackage 68788-8733-03. 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)
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 tablets are a histamine-2 (H 2 ) receptor antagonist indicated ( ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • activ…
Excerpt only. Read the full label for complete information.
About NDC 68788-8733
- What is NDC 68788-8733?
- 68788-8733 is the product NDC for Famotidine, Famotidine 40 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 4 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 215767
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 Reducerfamotidine | Famotidine 20 mg/1 | TabletOral | Allegiant Health | 69168-445 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-017 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-018 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6790 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7178 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7180 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7196 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-937 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2264 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2330 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3786 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2527 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-331 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-427 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-589 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0329 |