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 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-825
Product ID 43353-825_ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071307
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 43353825
Hyphenated Format 43353-825

Supplemental Identifiers

RxCUI
197590
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 ANDA071307 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43353-825-30)
  • 60 TABLET in 1 BOTTLE (43353-825-53)
  • 90 TABLET in 1 BOTTLE (43353-825-60)
  • 120 TABLET in 1 BOTTLE (43353-825-70)
source: ndc

Packages (4)

43353-825-30 30 TABLET in 1 BOTTLE (43353-825-30) 43353-825-53 60 TABLET in 1 BOTTLE (43353-825-53) 43353-825-60 90 TABLET in 1 BOTTLE (43353-825-60) 43353-825-70 120 TABLET in 1 BOTTLE (43353-825-70)

Ingredients (1)

diazepam (2 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": "ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197590"], "spl_set_id": ["b29916fb-1781-4112-9c3e-45478754d638"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-825-30)", "package_ndc": "43353-825-30", "marketing_start_date": "20130308"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-825-53)", "package_ndc": "43353-825-53", "marketing_start_date": "20130308"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-825-60)", "package_ndc": "43353-825-60", "marketing_start_date": "20130308"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (43353-825-70)", "package_ndc": "43353-825-70", "marketing_start_date": "20130308"}], "brand_name": "Diazepam", "product_id": "43353-825_ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43353-825", "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": "2 mg/1"}], "application_number": "ANDA071307", "marketing_category": "ANDA", "marketing_start_date": "19861210", "listing_expiration_date": "20261231"}