diazepam intensol

Generic: diazepam intensol

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam intensol
Generic Name diazepam intensol
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

diazepam 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3185
Product ID 0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071415
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1987-04-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543185
Hyphenated Format 0054-3185

Supplemental Identifiers

RxCUI
309844
UNII
Q3JTX2Q7TU
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 diazepam intensol (source: ndc)
Generic Name diazepam intensol (source: ndc)
Application Number ANDA071415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-3185-44 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE

Ingredients (1)

diazepam (5 mg/mL)

Linked Drug Pages (1)

Diazepam Intensol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ab533d6f-4e34-4675-9da6-b93484134aca", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309844"], "spl_set_id": ["1aaf9375-ae3d-4fed-9cd1-24102e00be1a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-3185-44)  / 30 mL in 1 BOTTLE", "package_ndc": "0054-3185-44", "marketing_start_date": "19870403"}], "brand_name": "Diazepam Intensol", "product_id": "0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0054-3185", "dea_schedule": "CIV", "generic_name": "Diazepam Intensol", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam Intensol", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/mL"}], "application_number": "ANDA071415", "marketing_category": "ANDA", "marketing_start_date": "19870403", "listing_expiration_date": "20261231"}