Ranitidine
- Product NDC
- 65162-664
- 11-digit product format
- 651620664
- Labeler code
- 65162
- Product ID
- 65162-664_022a0dc5-868f-4c73-a9f9-a6cd4c7c5331
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranitidine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078312
- Marketing category
- ANDA
- Marketing start
- 2010-03-12
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-664 | RANITIDINE SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 10 | Legacy NDC | 20241031_8f0bb213-6342-4fea-a080-24def590d1ba.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 |
|---|
| 65162-664-90 | 65162066490 | 473 mL in 1 BOTTLE (65162-664-90) | 473 ml | 2010-03-12 | 0000-00-00 | No | No | Current |