Ranitidine
- Product NDC
- 0121-0727
- 11-digit product format
- 001210727
- Labeler code
- 0121
- Product ID
- 0121-0727_d56a22ea-5dab-e98a-e053-2a95a90a34c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANITIDINE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA077405
- Marketing category
- ANDA
- Marketing start
- 2010-11-01
- Substance
- RANITIDINE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ranitidine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RANITIDINE | 15 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 884KT10YB7 |
| Rxcui | 705610 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0727-16 | Ranitidine | 473 mL in 1 BOTTLE | SYRUP | 473 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0727-16 | ML - Milliliter | 0121-0727 | 3875e311-254e-4d50-bcc2-e8105917adf6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Ranitidine | ACTIVE INGREDIENT | 884KT10YB7 | RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| Ranitidine | ACTIVE MOIETY | 884KT10YB7 | RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 705610 | ranitidine 15 MG/ML Oral Solution | SCD | d0da9dd6-c691-4614-99c7-531b0bf34837 | 8 |
| 705610 | ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution | SY | d0da9dd6-c691-4614-99c7-531b0bf34837 | 8 |
| 705610 | ranitidine 75 MG per 5 ML Syrup | SY | d0da9dd6-c691-4614-99c7-531b0bf34837 | 8 |
| 705610 | ranitidine 15 MG/ML Oral Solution | SCD | 6a10f978-be03-1362-e053-2991aa0a4c1f | 4 |
| 705610 | ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution | SY | 6a10f978-be03-1362-e053-2991aa0a4c1f | 4 |
| 705610 | ranitidine 75 MG per 5 ML Syrup | SY | 6a10f978-be03-1362-e053-2991aa0a4c1f | 4 |
| 705610 | ranitidine 15 MG/ML Oral Solution | SCD | 361f8a7e-eeba-4941-9868-eaffbc04ba7e | 3 |
| 705610 | ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution | SY | 361f8a7e-eeba-4941-9868-eaffbc04ba7e | 3 |
| 705610 | ranitidine 75 MG per 5 ML Syrup | SY | 361f8a7e-eeba-4941-9868-eaffbc04ba7e | 3 |
| 705610 | ranitidine 15 MG/ML Oral Solution | SCD | 817c4a6c-a89c-4d86-87a3-895bbc8fb4ad | 2 |
| 705610 | ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution | SY | 817c4a6c-a89c-4d86-87a3-895bbc8fb4ad | 2 |
| 705610 | ranitidine 75 MG per 5 ML Syrup | SY | 817c4a6c-a89c-4d86-87a3-895bbc8fb4ad | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0121-0727-16 | 00121072716 | 473 mL in 1 BOTTLE (0121-0727-16) | 473 ml | 2010-11-01 | 0000-00-00 | No | No | Current |