Ranitidine
- Product NDC
- 55315-352
- 11-digit product format
- 553150352
- Labeler code
- 55315
- Product ID
- 55315-352_b1e38847-000e-4d7f-8b6f-d4252c2884f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ranitidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Fred's Inc.
- Application
- ANDA201745
- Marketing category
- ANDA
- Marketing start
- 2013-09-01
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 75 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 55315-352-31 | Ranitidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 55315-352-31 | Ranitidine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55315-352 | RANITIDINE TABLET, FILM COATED [FRED'S INC.] | 1 | Legacy NDC, 2 package rows | 20130901_6af31f34-2a2f-4532-8268-63729794f73a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55315-352-31 | 55315035231 | 1 in 1 CARTON | Historical |