Ranitidine
- Product NDC
- 33261-099
- 11-digit product format
- 332610099
- Labeler code
- 33261
- Product ID
- 33261-099_99a8f78f-d074-4c2a-8dff-b0637b2a2324
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranitidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077824
- Marketing category
- ANDA
- Marketing start
- 2009-12-16
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 33261-099-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
| 33261-099-99 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c613-f424-e053-dadaa90a57ce | Ranitidine Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-099-02 | Ranitidine | 120 in 1 BOTTLE | TABLET | 120 | 7 | |
| 33261-099-10 | Ranitidine | 10 in 1 BOTTLE | TABLET | 10 | 7 | |
| 33261-099-20 | Ranitidine | 20 in 1 BOTTLE | TABLET | 20 | 7 | |
| 33261-099-30 | Ranitidine | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 33261-099-60 | Ranitidine | 60 in 1 BOTTLE | TABLET | 60 | 7 | |
| 33261-099-90 | Ranitidine | 90 in 1 BOTTLE | TABLET | 90 | 7 | |
| 33261-099-99 | Ranitidine | 180 in 1 BOTTLE | TABLET | 180 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-099-02 | EA - Each | 33261-099 | ace13021-8a4f-4931-be1d-2fd73145f588 | 1 | 2015-10-02 |
| 33261-099-20 | EA - Each | 33261-099 | 3123003a-ff9a-47cb-a4ce-ac9e632dca44 | 1 | 2015-10-02 |
| 33261-099-30 | EA - Each | 33261-099 | b7d4dd7c-53c4-400f-84b9-2263885f0bfb | 1 | 2015-10-02 |
| 33261-099-60 | EA - Each | 33261-099 | 49a55f47-69da-4599-90a7-d30bddd96850 | 1 | 2015-10-02 |
| 33261-099-90 | EA - Each | 33261-099 | ec2caf37-6114-4ace-ba26-d1450dbcaeb2 | 1 | 2015-10-02 |
| 33261-099-99 | EA - Each | 33261-099 | 84b11a3c-5d2b-437f-8cbb-0b25806772e2 | 1 | 2017-12-14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | BK76465IHM | RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| RANITIDINE | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198191 | ranitidine 150 MG Oral Tablet | PSN | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
| 198193 | ranitidine 300 MG Oral Tablet | PSN | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
| 198191 | ranitidine 150 MG Oral Tablet | SCD | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
| 198193 | ranitidine 300 MG Oral Tablet | SCD | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
| 198191 | ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet | SY | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
| 198193 | ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet | SY | 9add19e6-f71c-4950-ae63-90e152a9cfe0 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-099-02 | 33261009902 | 120 in 1 BOTTLE | Historical |
| 33261-099-10 | 33261009910 | 10 in 1 BOTTLE | Historical |
| 33261-099-20 | 33261009920 | 20 in 1 BOTTLE | Historical |
| 33261-099-30 | 33261009930 | 30 in 1 BOTTLE | Historical |
| 33261-099-60 | 33261009960 | 60 in 1 BOTTLE | Historical |
| 33261-099-90 | 33261009990 | 90 in 1 BOTTLE | Historical |
| 33261-099-99 | 33261009999 | 180 in 1 BOTTLE | Historical |