diazepam

Generic: diazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-424
Product ID 71610-424_674e8116-e236-44a6-92f3-2f33fde550fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071322
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1986-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610424
Hyphenated Format 71610-424

Supplemental Identifiers

RxCUI
197589
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 ANDA071322 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-424-15)
  • 30 TABLET in 1 BOTTLE (71610-424-30)
  • 45 TABLET in 1 BOTTLE (71610-424-45)
  • 60 TABLET in 1 BOTTLE (71610-424-53)
  • 90 TABLET in 1 BOTTLE (71610-424-60)
  • 120 TABLET in 1 BOTTLE (71610-424-70)
source: ndc

Packages (6)

71610-424-15 15 TABLET in 1 BOTTLE (71610-424-15) 71610-424-30 30 TABLET in 1 BOTTLE (71610-424-30) 71610-424-45 45 TABLET in 1 BOTTLE (71610-424-45) 71610-424-53 60 TABLET in 1 BOTTLE (71610-424-53) 71610-424-60 90 TABLET in 1 BOTTLE (71610-424-60) 71610-424-70 120 TABLET in 1 BOTTLE (71610-424-70)

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": "674e8116-e236-44a6-92f3-2f33fde550fd", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589"], "spl_set_id": ["9cf031ae-d59b-430d-9b15-415ae2e49c98"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-424-15)", "package_ndc": "71610-424-15", "marketing_start_date": "20220901"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-424-30)", "package_ndc": "71610-424-30", "marketing_start_date": "20200507"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-424-45)", "package_ndc": "71610-424-45", "marketing_start_date": "20220804"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-424-53)", "package_ndc": "71610-424-53", "marketing_start_date": "20200507"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-424-60)", "package_ndc": "71610-424-60", "marketing_start_date": "20200507"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-424-70)", "package_ndc": "71610-424-70", "marketing_start_date": "20200507"}], "brand_name": "Diazepam", "product_id": "71610-424_674e8116-e236-44a6-92f3-2f33fde550fd", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-424", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "10 mg/1"}], "application_number": "ANDA071322", "marketing_category": "ANDA", "marketing_start_date": "19861210", "listing_expiration_date": "20261231"}