Ranitidine
- Product NDC
- 21695-109
- 11-digit product format
- 216950109
- Labeler code
- 21695
- Product ID
- 21695-109_dcee67ac-e58c-4050-ad16-f8253a17036b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranitidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors
- Application
- ANDA077824
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- 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#
| 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 |
|---|---|---|---|---|---|
| 21695-109-00 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
| 21695-109-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
| 21695-109-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
| 21695-109-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
| 21695-109-72 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
| 21695-109-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b33-48b1-e053-8cdaa90a720a | Ranitidine Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-109-00 | Ranitidine | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 21695-109-14 | Ranitidine | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 21695-109-30 | Ranitidine | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-109-60 | Ranitidine | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-109-72 | Ranitidine | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 21695-109-90 | Ranitidine | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-109-00 | EA - Each | 21695-109 | ee24a758-3437-47eb-b440-104287c5eb98 | 1 | 2012-07-24 |
| 21695-109-14 | EA - Each | 21695-109 | c0b180a3-2158-48ac-ae51-90a8f3d60443 | 1 | 2012-07-24 |
| 21695-109-30 | EA - Each | 21695-109 | 244162e9-9d5d-47e7-88f7-09c42fa87eaa | 1 | 2012-07-24 |
| 21695-109-60 | EA - Each | 21695-109 | 2f78467b-8d4c-498d-8328-b326bac49530 | 1 | 2012-07-24 |
| 21695-109-72 | EA - Each | 21695-109 | feea6f9e-6b5a-4717-8a53-e8605bc30280 | 1 | 2012-07-24 |
| 21695-109-90 | EA - Each | 21695-109 | 2a1aed57-2a36-4efa-860e-a21ee20742f2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS] | 1 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198191 | ranitidine 150 MG Oral Tablet | PSN | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
| 198193 | ranitidine 300 MG Oral Tablet | PSN | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
| 198191 | ranitidine 150 MG Oral Tablet | SCD | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
| 198193 | ranitidine 300 MG Oral Tablet | SCD | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
| 198191 | ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet | SY | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
| 198193 | ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet | SY | a9fef8f6-b823-4b8a-84b8-2b916374adb5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-109-00 | 21695010900 | 100 in 1 BOTTLE | Historical |
| 21695-109-14 | 21695010914 | 14 in 1 BOTTLE | Historical |
| 21695-109-30 | 21695010930 | 30 in 1 BOTTLE | Historical |
| 21695-109-60 | 21695010960 | 60 in 1 BOTTLE | Historical |
| 21695-109-72 | 21695010972 | 120 in 1 BOTTLE | Historical |
| 21695-109-90 | 21695010990 | 90 in 1 BOTTLE | Historical |