alprazolam

Generic: alprazolam

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler endo usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

alprazolam 1 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-213
Product ID 49884-213_fac25045-6d3b-420d-b2c0-f2f211236e15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078088
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884213
Hyphenated Format 49884-213

Supplemental Identifiers

RxCUI
485413 485414 485415 485416
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 ANDA078088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (49884-213-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

alprazolam (1 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fac25045-6d3b-420d-b2c0-f2f211236e15", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["YU55MQ3IZY"], "rxcui": ["485413", "485414", "485415", "485416"], "spl_set_id": ["ff1630b4-2044-433c-96bc-0bb4ae8d42a0"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (49884-213-74)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "49884-213-74", "marketing_start_date": "20090109"}], "brand_name": "Alprazolam", "product_id": "49884-213_fac25045-6d3b-420d-b2c0-f2f211236e15", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "49884-213", "dea_schedule": "CIV", "generic_name": "alprazolam", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": "1 mg/1"}], "application_number": "ANDA078088", "marketing_category": "ANDA", "marketing_start_date": "20090109", "listing_expiration_date": "20261231"}