Nizatidine
- Product NDC
- 55111-311
- 11-digit product format
- 551110311
- Labeler code
- 55111
- Product ID
- 55111-311_254e5866-1ba8-8d97-bc03-19916119ff87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nizatidine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr Reddy's Laboratories Limited
- Application
- ANDA077314
- Marketing category
- ANDA
- Marketing start
- 2005-09-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nizatidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIZATIDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P41PML4GHR |
| Rxcui | 198041, 312025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-311 | NIZATIDINE CAPSULE [DR REDDY'S LABORATORIES LIMITED] | 3 | Current NDC, Legacy NDC, 6 package rows | 20190312_faaa7cc4-fda9-d5b8-de2a-71c8744ccb76.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 |
|---|
| 55111-311-01 | 55111031101 | 100 CAPSULE in 1 BOTTLE (55111-311-01) | 100 capsule | 2005-09-15 | 0000-00-00 | No | No | Current |
| 55111-311-05 | 55111031105 | 500 CAPSULE in 1 BOTTLE (55111-311-05) | 500 capsule | 2005-09-15 | 0000-00-00 | No | No | Current |
| 55111-311-30 | 55111031130 | 30 CAPSULE in 1 BOTTLE (55111-311-30) | 30 capsule | 2005-09-15 | 0000-00-00 | No | No | Current |
| 55111-311-60 | 55111031160 | 60 CAPSULE in 1 BOTTLE (55111-311-60) | 60 capsule | 2005-09-15 | 0000-00-00 | No | No | Current |
| 55111-311-78 | 55111031178 | 10 BLISTER PACK in 1 CARTON (55111-311-78) / 10 CAPSULE in 1 BLISTER PACK (55111-311-79) | 10 blister pack | 2005-09-15 | 0000-00-00 | No | No | Current |
| 55111-311-79 | 55111031179 | 10 in 1 BLISTER PACK | | | | | | Historical |