alprazolam

Generic: alprazolam

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alprazolam 3 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-813
Product ID 65162-813_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078387
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-12-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162813
Hyphenated Format 65162-813

Supplemental Identifiers

RxCUI
433798 433799 433800 433801
UPC
0365162809503 0365162810509 0365162813500 0365162809039 0365162810035 0365162813036 0365162812039 0365162812503
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 ANDA078387 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-03)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-06)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-50)
source: ndc

Packages (3)

65162-813-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-03) 65162-813-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-06) 65162-813-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-50)

Ingredients (1)

alprazolam (3 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": "4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0365162809503", "0365162810509", "0365162813500", "0365162809039", "0365162810035", "0365162813036", "0365162812039", "0365162812503"], "unii": ["YU55MQ3IZY"], "rxcui": ["433798", "433799", "433800", "433801"], "spl_set_id": ["259387c1-e374-4bc2-9510-5f7f2c60d1a5"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-03)", "package_ndc": "65162-813-03", "marketing_start_date": "20091203"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-06)", "package_ndc": "65162-813-06", "marketing_start_date": "20091203"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-50)", "package_ndc": "65162-813-50", "marketing_start_date": "20091203"}], "brand_name": "Alprazolam", "product_id": "65162-813_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "65162-813", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "3 mg/1"}], "application_number": "ANDA078387", "marketing_category": "ANDA", "marketing_start_date": "20091203", "listing_expiration_date": "20261231"}