NIZATIDINE
- Product NDC
- 60846-301
- 11-digit product format
- 608460301
- Labeler code
- 60846
- Product ID
- 60846-301_aedc4160-2165-451e-8a3b-26d3bb911242
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NIZATIDINE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA090576
- Marketing category
- ANDA
- Marketing start
- 2016-08-12
- Substance
- NIZATIDINE
- Active strength
- 15 mg/mL
- 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 | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P41PML4GHR |
| Rxcui | 476872 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60846-301-15 | NIZATIDINE | 480 mL in 1 BOTTLE | SOLUTION | 480 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60846-301 | NIZATIDINE SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241025_39e62997-8781-449a-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60846-301-15 | 60846030115 | 480 mL in 1 BOTTLE (60846-301-15) | 480 ml | 2016-08-12 | 0000-00-00 | No | No | Current |