alprazolam

Generic: alprazolam

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler aurobindo pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

alprazolam 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-455
Product ID 65862-455_f2273fea-bd3b-4ef5-b698-73ba677722e3
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 65862455
Hyphenated Format 65862-455

Supplemental Identifiers

RxCUI
433798 433799 433800 433801
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 ANDA090871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-60)
  • 7000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-71)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-99)
source: ndc

Packages (3)

65862-455-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-60) 65862-455-71 7000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-71) 65862-455-99 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-99)

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": "f2273fea-bd3b-4ef5-b698-73ba677722e3", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["433798", "433799", "433800", "433801"], "spl_set_id": ["326fa31a-5420-429b-9f7f-170cb38f64bd"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-60)", "package_ndc": "65862-455-60", "marketing_start_date": "20110607"}, {"sample": false, "description": "7000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-71)", "package_ndc": "65862-455-71", "marketing_start_date": "20110607"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-455-99)", "package_ndc": "65862-455-99", "marketing_start_date": "20110607"}], "brand_name": "Alprazolam", "product_id": "65862-455_f2273fea-bd3b-4ef5-b698-73ba677722e3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "65862-455", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "1 mg/1"}], "application_number": "ANDA090871", "marketing_category": "ANDA", "marketing_start_date": "20110607", "listing_expiration_date": "20261231"}