Nizatidine
- Product NDC
- 52959-824
- 11-digit product format
- 529590824
- Labeler code
- 52959
- Product ID
- 52959-824_6dce31da-352d-47ef-9f8d-d4e2466a06a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nizatidine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA075616
- Marketing category
- ANDA
- Marketing start
- 2002-07-09
- 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
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 52959-824-30 | Nizatidine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 1 |
| 52959-824-60 | Nizatidine | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NIZATIDINE | ACTIVE INGREDIENT | P41PML4GHR | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| NIZATIDINE | ACTIVE MOIETY | P41PML4GHR | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FERRIC OXIDE BLACK | INACTIVE INGREDIENT | XM0M87F357 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-824 | NIZATIDINE CAPSULE [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 2 package rows | 20111209_33cf4324-44cb-44df-b459-7319a335b253.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-824-30 | 52959082430 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 52959-824-60 | 52959082460 | 60 in 1 BOTTLE, PLASTIC | Historical |