Alprazolam
- Product NDC
- 21695-249
- 11-digit product format
- 216950249
- Labeler code
- 21695
- Product ID
- 21695-249_4f300492-4080-499d-b872-a8bf9de3cc7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA074112
- Marketing category
- ANDA
- Marketing start
- 1999-12-29
- Marketing end
- 0000-00-00
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-249-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-47eb-48b1-e053-8cdaa90a720a | Alprazolam Tablets, USP |
| 21695-249-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-47eb-48b1-e053-8cdaa90a720a | Alprazolam Tablets, USP |
| 21695-249-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-47eb-48b1-e053-8cdaa90a720a | Alprazolam Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-249-30 | Alprazolam | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-249-45 | Alprazolam | 45 in 1 BOTTLE | TABLET | 45 | 1 | |
| 21695-249-60 | Alprazolam | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-249-30 | EA - Each | 21695-249 | 1176a561-4656-4179-8bb4-6e472dfc7fe4 | 1 | 2012-07-24 |
| 21695-249-45 | EA - Each | 21695-249 | 7f6314b3-71df-4da5-bb60-bc6c2db17a72 | 1 | 2012-07-24 |
| 21695-249-60 | EA - Each | 21695-249 | 1ca4cb01-6c05-4caa-b7dc-ac7bc8fb4753 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Alprazolam | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Alprazolam | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| docusate sodium | INACTIVE INGREDIENT | F05Q2T2JA0 | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308047 | ALPRAZolam 0.25 MG Oral Tablet | PSN | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 308048 | ALPRAZolam 0.5 MG Oral Tablet | PSN | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 197321 | ALPRAZolam 1 MG Oral Tablet | PSN | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 197322 | ALPRAZolam 2 MG Oral Tablet | PSN | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 308047 | alprazolam 0.25 MG Oral Tablet | SCD | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 308048 | alprazolam 0.5 MG Oral Tablet | SCD | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 197321 | alprazolam 1 MG Oral Tablet | SCD | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
| 197322 | alprazolam 2 MG Oral Tablet | SCD | d7a54ceb-2d80-4879-950f-cad362324086 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-249-30 | 21695024930 | 30 in 1 BOTTLE | Historical |
| 21695-249-45 | 21695024945 | 45 in 1 BOTTLE | Historical |
| 21695-249-60 | 21695024960 | 60 in 1 BOTTLE | Historical |