diazepam

Generic: diazepam

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

Drug Facts

Product Profile

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

diazepam 10 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-286
Product ID 51079-286_3a39f676-7a52-3d33-e063-6294a90a4123
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070325
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1997-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079286
Hyphenated Format 51079-286

Supplemental Identifiers

RxCUI
197589 197590 197591
UNII
Q3JTX2Q7TU
NUI
N0000175694 M0002356

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
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-286-20) / 1 TABLET in 1 BLISTER PACK (51079-286-01)
source: ndc

Packages (1)

51079-286-20 100 BLISTER PACK in 1 CARTON (51079-286-20) / 1 TABLET in 1 BLISTER PACK (51079-286-01)

Ingredients (1)

diazepam (10 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": "3a39f676-7a52-3d33-e063-6294a90a4123", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589", "197590", "197591"], "spl_set_id": ["b326c66d-5762-4d16-933c-619fa2088ccd"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-286-20)  / 1 TABLET in 1 BLISTER PACK (51079-286-01)", "package_ndc": "51079-286-20", "marketing_start_date": "19971031"}], "brand_name": "Diazepam", "product_id": "51079-286_3a39f676-7a52-3d33-e063-6294a90a4123", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "51079-286", "dea_schedule": "CIV", "generic_name": "diazepam", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "10 mg/1"}], "application_number": "ANDA070325", "marketing_category": "ANDA", "marketing_start_date": "19971031", "listing_expiration_date": "20261231"}