Nizatidine
- Product NDC
- 42806-299
- 11-digit product format
- 428060299
- Labeler code
- 42806
- Product ID
- 42806-299_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
- 150 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nizatidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIZATIDINE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P41PML4GHR |
| Rxcui | 198041, 312025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-299-30 | Nizatidine | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 42806-299-60 | Nizatidine | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-299 | NIZATIDINE CAPSULE [EPIC PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20250104_e9957997-8b85-48a0-9bb3-b878cb223236.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-299-30 | 42806029930 | 30 CAPSULE in 1 BOTTLE (42806-299-30) | 30 capsule | 2024-10-25 | No | No | Current |
| 42806-299-60 | 42806029960 | 60 CAPSULE in 1 BOTTLE (42806-299-60) | 60 capsule | 2024-10-25 | No | No | Current |