estazolam

Generic: estazolam

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estazolam
Generic Name estazolam
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estazolam 2 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0745
Product ID 0591-0745_5189e5a6-f58a-4eab-ac95-9d8011d6f3db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074818
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1997-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910745
Hyphenated Format 0591-0745

Supplemental Identifiers

RxCUI
197653 197654
UPC
0305910745011 0305910744014
UNII
36S3EQV54C
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 estazolam (source: ndc)
Generic Name estazolam (source: ndc)
Application Number ANDA074818 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)
source: ndc

Packages (1)

0591-0745-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)

Ingredients (1)

estazolam (2 mg/1)

Linked Drug Pages (1)

Estazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5189e5a6-f58a-4eab-ac95-9d8011d6f3db", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0305910745011", "0305910744014"], "unii": ["36S3EQV54C"], "rxcui": ["197653", "197654"], "spl_set_id": ["a1e3b4bf-22e9-430a-a768-4d86ae886c9e"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)", "package_ndc": "0591-0745-01", "marketing_start_date": "19971001"}], "brand_name": "Estazolam", "product_id": "0591-0745_5189e5a6-f58a-4eab-ac95-9d8011d6f3db", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0591-0745", "dea_schedule": "CIV", "generic_name": "Estazolam", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estazolam", "active_ingredients": [{"name": "ESTAZOLAM", "strength": "2 mg/1"}], "application_number": "ANDA074818", "marketing_category": "ANDA", "marketing_start_date": "19971001", "listing_expiration_date": "20261231"}