RANITIDINE
- Product NDC
- 55648-907
- 11-digit product format
- 556480907
- Labeler code
- 55648
- Product ID
- 55648-907_fbd61078-7ec6-4081-a730-4de11b7087a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANITIDINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- WOCKHARDT LIMITED
- Application
- ANDA075208
- Marketing category
- ANDA
- Marketing start
- 1998-12-17
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 300 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7f54af34-be54-4c3c-894f-78df6452d747 | Product name | 3 | 20190703 |
| ccf8541e-b7dc-e6ba-06c9-15bf143a7850 | Product name | 5 | 20190611 |
| 05700d9e-ea6f-4aab-b0ed-1488f1d85d7b | Product name | 1 | 20180904 |
| 2f9d4e5c-e179-490e-8c43-f19e1e0ca228 | Product name | 1 | 20160720 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55648-907-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
| 55648-907-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
| 55648-907-03 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
| 55648-907-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
| 55648-907-08 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
| 55648-907-09 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c081-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55648-907-01 | RANITIDINE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 55648-907-02 | RANITIDINE | 250 in 1 BOTTLE | TABLET | 250 | 1 | |
| 55648-907-03 | RANITIDINE | 10 in 1 CARTON | TABLET | 10 | 1 | |
| 55648-907-03 | RANITIDINE | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 55648-907-04 | RANITIDINE | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 55648-907-08 | RANITIDINE | 7500 in 1 DRUM | TABLET | 7500 | 1 | |
| 55648-907-09 | RANITIDINE | 3750 in 1 DRUM | TABLET | 3750 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RANITIDINE TABLET [WOCKHARDT LIMITED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198191 | ranitidine 150 MG Oral Tablet | PSN | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
| 198193 | ranitidine 300 MG Oral Tablet | PSN | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
| 198191 | ranitidine 150 MG Oral Tablet | SCD | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
| 198193 | ranitidine 300 MG Oral Tablet | SCD | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
| 198191 | ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet | SY | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
| 198193 | ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet | SY | ea789ea3-c9a4-44e8-a667-a478f3594342 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 55648-907-01 | 55648090701 | 30 in 1 BOTTLE | Historical |
| 55648-907-02 | 55648090702 | 250 in 1 BOTTLE | Historical |
| 55648-907-03 | 55648090703 | 10 in 1 CARTON | Historical |
| 55648-907-04 | 55648090704 | 100 in 1 BOTTLE | Historical |
| 55648-907-08 | 55648090708 | 7500 in 1 DRUM | Historical |
| 55648-907-09 | 55648090709 | 3750 in 1 DRUM | Historical |