diazepam

Generic: diazepam

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-544
Product ID 63187-544_aeef8cde-a187-453e-b7fb-e179493ff427
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 63187544
Hyphenated Format 63187-544

Supplemental Identifiers

RxCUI
197589
UPC
0363187544300
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
  • 6 TABLET in 1 BOTTLE (63187-544-06)
  • 15 TABLET in 1 BOTTLE (63187-544-15)
  • 20 TABLET in 1 BOTTLE (63187-544-20)
  • 30 TABLET in 1 BOTTLE (63187-544-30)
  • 60 TABLET in 1 BOTTLE (63187-544-60)
  • 90 TABLET in 1 BOTTLE (63187-544-90)
source: ndc

Packages (6)

63187-544-06 6 TABLET in 1 BOTTLE (63187-544-06) 63187-544-15 15 TABLET in 1 BOTTLE (63187-544-15) 63187-544-20 20 TABLET in 1 BOTTLE (63187-544-20) 63187-544-30 30 TABLET in 1 BOTTLE (63187-544-30) 63187-544-60 60 TABLET in 1 BOTTLE (63187-544-60) 63187-544-90 90 TABLET in 1 BOTTLE (63187-544-90)

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": "aeef8cde-a187-453e-b7fb-e179493ff427", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0363187544300"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589"], "spl_set_id": ["f8d26f65-a015-4bfc-b1fa-8595d72af48c"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (63187-544-06)", "package_ndc": "63187-544-06", "marketing_start_date": "20191217"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (63187-544-15)", "package_ndc": "63187-544-15", "marketing_start_date": "20181201"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (63187-544-20)", "package_ndc": "63187-544-20", "marketing_start_date": "20181201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-544-30)", "package_ndc": "63187-544-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-544-60)", "package_ndc": "63187-544-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-544-90)", "package_ndc": "63187-544-90", "marketing_start_date": "20181201"}], "brand_name": "Diazepam", "product_id": "63187-544_aeef8cde-a187-453e-b7fb-e179493ff427", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "63187-544", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Proficient Rx LP", "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"}