alprazolam

Generic: alprazolam

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

alprazolam 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3068
Product ID 0054-3068_d7b8cdff-1337-4ef6-a5fb-654f1d655bfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074312
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1993-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543068
Hyphenated Format 0054-3068

Supplemental Identifiers

RxCUI
308050
UNII
YU55MQ3IZY
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 ANDA074312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-3068-44 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE

Ingredients (1)

alprazolam (1 mg/mL)

Linked Drug Pages (1)

Alprazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7b8cdff-1337-4ef6-a5fb-654f1d655bfe", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["308050"], "spl_set_id": ["b945ac6f-796e-41ef-85e9-61007e4a4e9a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CONTAINER (0054-3068-44)  / 30 mL in 1 BOTTLE", "package_ndc": "0054-3068-44", "marketing_start_date": "19931031"}], "brand_name": "Alprazolam", "product_id": "0054-3068_d7b8cdff-1337-4ef6-a5fb-654f1d655bfe", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0054-3068", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "1 mg/mL"}], "application_number": "ANDA074312", "marketing_category": "ANDA", "marketing_start_date": "19931031", "listing_expiration_date": "20261231"}