alprazolam

Generic: alprazolam

Labeler: preferredpharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler preferredpharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alprazolam 1 mg/1

Manufacturer
PreferredPharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8394
Product ID 68788-8394_e63a8f38-e1a8-474c-bedb-abba635dcd95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203346
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2023-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888394
Hyphenated Format 68788-8394

Supplemental Identifiers

RxCUI
197321
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
  • 100 TABLET in 1 BOTTLE (68788-8394-1)
  • 20 TABLET in 1 BOTTLE (68788-8394-2)
  • 30 TABLET in 1 BOTTLE (68788-8394-3)
  • 60 TABLET in 1 BOTTLE (68788-8394-6)
  • 90 TABLET in 1 BOTTLE (68788-8394-9)
source: ndc

Packages (5)

68788-8394-1 100 TABLET in 1 BOTTLE (68788-8394-1) 68788-8394-2 20 TABLET in 1 BOTTLE (68788-8394-2) 68788-8394-3 30 TABLET in 1 BOTTLE (68788-8394-3) 68788-8394-6 60 TABLET in 1 BOTTLE (68788-8394-6) 68788-8394-9 90 TABLET in 1 BOTTLE (68788-8394-9)

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": "e63a8f38-e1a8-474c-bedb-abba635dcd95", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["197321"], "spl_set_id": ["dc130aae-4510-4de7-a750-4a144e88208d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PreferredPharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8394-1)", "package_ndc": "68788-8394-1", "marketing_start_date": "20230301"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8394-2)", "package_ndc": "68788-8394-2", "marketing_start_date": "20230301"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8394-3)", "package_ndc": "68788-8394-3", "marketing_start_date": "20230301"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8394-6)", "package_ndc": "68788-8394-6", "marketing_start_date": "20230301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8394-9)", "package_ndc": "68788-8394-9", "marketing_start_date": "20230301"}], "brand_name": "Alprazolam", "product_id": "68788-8394_e63a8f38-e1a8-474c-bedb-abba635dcd95", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68788-8394", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "PreferredPharmaceuticals Inc.", "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": "20230301", "listing_expiration_date": "20271231"}