Nizatidine
- Product NDC
- 68462-425
- 11-digit product format
- 684620425
- Labeler code
- 68462
- Product ID
- 68462-425_d5f77199-a705-41d7-a283-c2d8e4a4ea57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nizatidine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090618
- Marketing category
- ANDA
- Marketing start
- 2011-07-15
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5c362336-b506-4bdc-6f70-74c97a4a3342 | Product name | 1 | 20140508 |
| 6f755c6f-b906-f8da-e39d-305610ef9195 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-425-60 | EA - Each | 68462-425 | 1ada70b2-c6aa-4c80-90da-f0d5445df351 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NIZATIDINE | ACTIVE INGREDIENT | P41PML4GHR | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| NIZATIDINE | ACTIVE MOIETY | P41PML4GHR | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312025 | nizatidine 150 MG Oral Capsule | PSN | 1d6161e3-2ddb-5446-e054-00144ff8d46c | 1 |
| 312025 | nizatidine 150 MG Oral Capsule | SCD | 1d6161e3-2ddb-5446-e054-00144ff8d46c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-425-01 | 68462042501 | 100 CAPSULE in 1 BOTTLE (68462-425-01) | 100 capsule | 2011-07-15 | 0000-00-00 | No | No | Current |
| 68462-425-60 | 68462042560 | 60 CAPSULE in 1 BOTTLE (68462-425-60) | 60 capsule | 2011-07-15 | 0000-00-00 | No | No | Current |