diazepam

Generic: diazepam

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

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0345
Product ID 0378-0345_983a3fdc-04ca-4621-a57c-56ad36015d36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070325
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 1985-09-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780345
Hyphenated Format 0378-0345

Supplemental Identifiers

RxCUI
197589 197590 197591
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 (source: ndc)
Generic Name diazepam (source: ndc)
Application Number ANDA070325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0345-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (0378-0345-05)
source: ndc

Packages (2)

0378-0345-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0345-01) 0378-0345-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-0345-05)

Ingredients (1)

diazepam (5 mg/1)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "983a3fdc-04ca-4621-a57c-56ad36015d36", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589", "197590", "197591"], "spl_set_id": ["c397a9da-862f-4f3f-8109-7d21691de53a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0345-01)", "package_ndc": "0378-0345-01", "marketing_start_date": "19850904"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0378-0345-05)", "package_ndc": "0378-0345-05", "marketing_start_date": "19850904"}], "brand_name": "Diazepam", "product_id": "0378-0345_983a3fdc-04ca-4621-a57c-56ad36015d36", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0378-0345", "dea_schedule": "CIV", "generic_name": "diazepam", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/1"}], "application_number": "ANDA070325", "marketing_category": "ANDA", "marketing_start_date": "19850904", "listing_expiration_date": "20271231"}