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 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-270
Product ID 71610-270_1ce73ca7-a651-40ea-9629-0e664017b5c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071321
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 71610270
Hyphenated Format 71610-270

Supplemental Identifiers

RxCUI
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 ANDA071321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-270-15)
  • 20 TABLET in 1 BOTTLE (71610-270-20)
  • 30 TABLET in 1 BOTTLE (71610-270-30)
  • 45 TABLET in 1 BOTTLE (71610-270-45)
  • 60 TABLET in 1 BOTTLE (71610-270-53)
  • 75 TABLET in 1 BOTTLE (71610-270-55)
  • 90 TABLET in 1 BOTTLE (71610-270-60)
  • 120 TABLET in 1 BOTTLE (71610-270-70)
  • 150 TABLET in 1 BOTTLE (71610-270-75)
  • 180 TABLET in 1 BOTTLE (71610-270-80)
  • 240 TABLET in 1 BOTTLE (71610-270-90)
source: ndc

Packages (11)

Ingredients (1)

diazepam (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1ce73ca7-a651-40ea-9629-0e664017b5c8", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197591"], "spl_set_id": ["bdb8feda-01c6-45bd-bd66-97196ccce70c"], "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 (71610-270-15)", "package_ndc": "71610-270-15", "marketing_start_date": "20190501"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71610-270-20)", "package_ndc": "71610-270-20", "marketing_start_date": "20190501"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-270-30)", "package_ndc": "71610-270-30", "marketing_start_date": "20190501"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-270-45)", "package_ndc": "71610-270-45", "marketing_start_date": "20190501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-270-53)", "package_ndc": "71610-270-53", "marketing_start_date": "20190501"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE (71610-270-55)", "package_ndc": "71610-270-55", "marketing_start_date": "20190501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-270-60)", "package_ndc": "71610-270-60", "marketing_start_date": "20190501"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-270-70)", "package_ndc": "71610-270-70", "marketing_start_date": "20190501"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (71610-270-75)", "package_ndc": "71610-270-75", "marketing_start_date": "20190501"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-270-80)", "package_ndc": "71610-270-80", "marketing_start_date": "20190501"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (71610-270-90)", "package_ndc": "71610-270-90", "marketing_start_date": "20190501"}], "brand_name": "Diazepam", "product_id": "71610-270_1ce73ca7-a651-40ea-9629-0e664017b5c8", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-270", "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": "5 mg/1"}], "application_number": "ANDA071321", "marketing_category": "ANDA", "marketing_start_date": "19861210", "listing_expiration_date": "20261231"}