alprazolam

Generic: alprazolam

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler asclemed usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alprazolam 2 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-653
Product ID 76420-653_0e42e402-85e4-30a1-e063-6394a90a142c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090871
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-06-07

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420653
Hyphenated Format 76420-653

Supplemental Identifiers

RxCUI
433798 433799 433800 433801
UNII
YU55MQ3IZY
NUI
N0000175694 M0002356

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alprazolam (source: ndc)
Generic Name alprazolam (source: ndc)
Application Number ANDA090871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-90)
source: ndc

Packages (3)

76420-653-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-30) 76420-653-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-60) 76420-653-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-90)

Ingredients (1)

alprazolam (2 mg/1)

Linked Drug Pages (1)

Alprazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e42e402-85e4-30a1-e063-6394a90a142c", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["433798", "433799", "433800", "433801"], "spl_set_id": ["5d839a8b-0f45-42bf-acc1-2bd28f948e53"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-30)", "package_ndc": "76420-653-30", "marketing_start_date": "20240105"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-60)", "package_ndc": "76420-653-60", "marketing_start_date": "20240105"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-90)", "package_ndc": "76420-653-90", "marketing_start_date": "20240105"}], "brand_name": "Alprazolam", "product_id": "76420-653_0e42e402-85e4-30a1-e063-6394a90a142c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76420-653", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "2 mg/1"}], "application_number": "ANDA090871", "marketing_category": "ANDA", "marketing_start_date": "20110607", "listing_expiration_date": "20261231"}