Prescription drug · ANDA
Famotidine NDC 68788-4119
Famotidine 20 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4119-1 | 68788411901 | 100 TABLET in 1 BOTTLE (68788-4119-1)Marketed from Jun 8, 2026 | |
| 68788-4119-3 | 68788411903 | 30 TABLET in 1 BOTTLE (68788-4119-3)Marketed from Jun 8, 2026 | |
| 68788-4119-4 | 68788411904 | 14 TABLET in 1 BOTTLE (68788-4119-4)Marketed from Jun 8, 2026 | |
| 68788-4119-6 | 68788411906 | 60 TABLET in 1 BOTTLE (68788-4119-6)Marketed from Jun 8, 2026 | |
| 68788-4119-8 | 68788411908 | 120 TABLET in 1 BOTTLE (68788-4119-8)Marketed from Jun 8, 2026 | |
| 68788-4119-9 | 68788411909 | 90 TABLET in 1 BOTTLE (68788-4119-9)Marketed from Jun 8, 2026 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078916
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68788-4119_32fd4101-15cb-411e-8b9d-270ec0592c6eSPL ID 32fd4101-15cb-411e-8b9d-270ec0592c6eSPL set ID 32fd4101-15cb-411e-8b9d-270ec0592c6eRxCUI 310273UNII 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
N468788411901followed by a unit qualifier and the quantityPackage 68788-4119-01. 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 tablet 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). • activ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078916
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 | TabletOral | Bryant Ranch Prepack | 71335-0409 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | direct rx | 72189-141 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3201 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Proficient Rx LP | 63187-723 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-293 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-294 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-077 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-001 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-002 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-399 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Proficient Rx LP | 63187-908 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0231 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8558 |
| Famotidine | Famotidine 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8559 |