estazolam

Generic: estazolam

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estazolam
Generic Name estazolam
Labeler novitium pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estazolam 1 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-480
Product ID 70954-480_2a612458-8b9a-4125-a783-44327a8166d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074826
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954480
Hyphenated Format 70954-480

Supplemental Identifiers

RxCUI
197653 197654
UPC
0370954480105 0370954481102
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 ANDA074826 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-480-10)
source: ndc

Packages (1)

70954-480-10 100 TABLET in 1 BOTTLE (70954-480-10)

Ingredients (1)

estazolam (1 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": "2a612458-8b9a-4125-a783-44327a8166d9", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0370954480105", "0370954481102"], "unii": ["36S3EQV54C"], "rxcui": ["197653", "197654"], "spl_set_id": ["e1c77eb1-9cba-4e89-a03f-9fb797add4f0"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-480-10)", "package_ndc": "70954-480-10", "marketing_start_date": "20210408"}], "brand_name": "Estazolam", "product_id": "70954-480_2a612458-8b9a-4125-a783-44327a8166d9", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70954-480", "dea_schedule": "CIV", "generic_name": "Estazolam", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estazolam", "active_ingredients": [{"name": "ESTAZOLAM", "strength": "1 mg/1"}], "application_number": "ANDA074826", "marketing_category": "ANDA", "marketing_start_date": "20210408", "listing_expiration_date": "20261231"}