Nizatidine
- Product NDC
- 42806-300
- 11-digit product format
- 428060300
- Labeler code
- 42806
- Product ID
- 42806-300_e9957997-8b85-48a0-9bb3-b878cb223236
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nizatidine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA076178
- Marketing category
- ANDA
- Marketing start
- 2024-10-25
- Substance
- NIZATIDINE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P41PML4GHR | NIZATIDINE | 76963-41-2 | NIZATIDINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-300-30 | 42806030030 | 30 CAPSULE in 1 BOTTLE (42806-300-30) | 30 capsule | 2024-10-25 | No | No | Historical |
| 42806-300-60 | 42806030060 | 60 CAPSULE in 1 BOTTLE (42806-300-60) | 60 capsule | 2024-10-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| NIZATIDINE CAPSULES, USP | Epic Pharma, LLC | 2025-01-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |