Ranitidine Hydrochloride
- Product NDC
- 68387-310
- 11-digit product format
- 683870310
- Labeler code
- 68387
- Product ID
- 68387-310_3c25b886-348e-490c-88ff-b7633a1efcb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranitidine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA074467
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 68387-310-30 | Ranitidine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 68387-310-60 | Ranitidine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSE 2910 (3 CPS) | INACTIVE INGREDIENT | 0VUT3PMY82 | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68387-310 | RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 2 package rows | 20100608_9ed8b5a6-4bbe-49dd-901b-1d86e8378bd3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68387-310-30 | 68387031030 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68387-310-60 | 68387031060 | 60 in 1 BOTTLE, PLASTIC | Historical |