Alprazolam
- Product NDC
- 45865-521
- 11-digit product format
- 458650521
- Labeler code
- 45865
- Product ID
- 45865-521_7e042b8e-50e4-d400-e053-2a91aa0a6ee7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA074112
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Marketing end
- 2019-07-31
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 2ffbe5ef-58ff-88b9-e291-045e0f861f4f | Product name | 4 | 20180827 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
|---|---|---|---|---|---|
| 45865-521-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eef7-f424-e053-dadaa90a57ce | Alprazolam Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45865-521-60 | Alprazolam | 60 in 1 BOTTLE | TABLET | 60 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197321 | ALPRAZolam 1 MG Oral Tablet | PSN | 1b67c155-5a70-2202-e054-00144ff8d46c | 2 |
| 197321 | alprazolam 1 MG Oral Tablet | SCD | 1b67c155-5a70-2202-e054-00144ff8d46c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 45865-521-60 | 45865052160 | 60 in 1 BOTTLE | Historical |