Alprazolam
- Product NDC
- 50436-4635
- 11-digit product format
- 504364635
- Labeler code
- 50436
- Product ID
- 50436-4635_33ff8d70-3013-44bc-b883-980b8488cd47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA074112
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Marketing end
- 0000-00-00
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ffbe5ef-58ff-88b9-e291-045e0f861f4f | Product name | 4 | 20180827 |
| 1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b | Product name | 1 | 20140508 |
| a1a11520-f3e2-68fa-8bd9-e80b271ef797 | Product name | 1 | 20140508 |
| d153678e-a3c8-bad8-cfe0-385656dde0e7 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-4635-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1a2a-a910-e053-dadaa90a0b85 | Alprazolam Tablets, USP CIV |
| 50436-4635-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1a2a-a910-e053-dadaa90a0b85 | Alprazolam Tablets, USP CIV |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4635-1 | Alprazolam | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 50436-4635-2 | Alprazolam | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-4635-1 | EA - Each | 50436-4635 | a74ef448-816f-496e-81d2-5244642a4853 | 1 | 2012-07-24 |
| 50436-4635-2 | EA - Each | 50436-4635 | 9f3a06f7-af49-4ae0-87ab-1fde0e3193d8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4635 | ALPRAZOLAM TABLET [UNIT DOSE SERVICES] | 3 | Legacy NDC, 2 package rows | 20190106_5abbc5cd-7c71-467e-ab9b-74ff29778420.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308048 | ALPRAZolam 0.5 MG Oral Tablet | PSN | 5abbc5cd-7c71-467e-ab9b-74ff29778420 | 3 |
| 308048 | alprazolam 0.5 MG Oral Tablet | SCD | 5abbc5cd-7c71-467e-ab9b-74ff29778420 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4635-1 | 50436463501 | 30 in 1 BOTTLE | Historical |
| 50436-4635-2 | 50436463502 | 60 in 1 BOTTLE | Historical |