alprazolam

Generic: alprazolam

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alprazolam 1 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-035
Product ID 50268-035_3fa15074-b724-8144-e063-6294a90a5c84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203346
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-08-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268035
Hyphenated Format 50268-035

Supplemental Identifiers

RxCUI
197321 308047 308048
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 ANDA203346 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-035-15) / 1 TABLET in 1 BLISTER PACK (50268-035-11)
source: ndc

Packages (1)

50268-035-15 50 BLISTER PACK in 1 BOX (50268-035-15) / 1 TABLET in 1 BLISTER PACK (50268-035-11)

Ingredients (1)

alprazolam (1 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": "3fa15074-b724-8144-e063-6294a90a5c84", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["197321", "308047", "308048"], "spl_set_id": ["3fa14fa4-45a7-6ef4-e063-6394a90a1dcd"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-035-15)  / 1 TABLET in 1 BLISTER PACK (50268-035-11)", "package_ndc": "50268-035-15", "marketing_start_date": "20250825"}], "brand_name": "Alprazolam", "product_id": "50268-035_3fa15074-b724-8144-e063-6294a90a5c84", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "50268-035", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "1 mg/1"}], "application_number": "ANDA203346", "marketing_category": "ANDA", "marketing_start_date": "20250825", "listing_expiration_date": "20261231"}