diazepam

Generic: diazepam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-970
Product ID 43063-970_415f6daf-09f1-78a5-e063-6294a90a9553
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 43063970
Hyphenated Format 43063-970

Supplemental Identifiers

RxCUI
197591
UPC
0343063970300
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
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-970-04)
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-970-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (43063-970-10)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-970-15)
  • 21 TABLET in 1 BOTTLE, PLASTIC (43063-970-21)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-970-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-970-60)
source: ndc

Packages (7)

43063-970-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-970-04) 43063-970-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-970-06) 43063-970-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-970-10) 43063-970-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-970-15) 43063-970-21 21 TABLET in 1 BOTTLE, PLASTIC (43063-970-21) 43063-970-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-970-30) 43063-970-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-970-60)

Ingredients (1)

diazepam (5 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": "415f6daf-09f1-78a5-e063-6294a90a9553", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0343063970300"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197591"], "spl_set_id": ["2483426d-3782-432a-8b8d-86c06ef0de4a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (43063-970-04)", "package_ndc": "43063-970-04", "marketing_start_date": "20190731"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-970-06)", "package_ndc": "43063-970-06", "marketing_start_date": "20190513"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43063-970-10)", "package_ndc": "43063-970-10", "marketing_start_date": "20200805"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-970-15)", "package_ndc": "43063-970-15", "marketing_start_date": "20191204"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (43063-970-21)", "package_ndc": "43063-970-21", "marketing_start_date": "20190507"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-970-30)", "package_ndc": "43063-970-30", "marketing_start_date": "20190501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-970-60)", "package_ndc": "43063-970-60", "marketing_start_date": "20191126"}], "brand_name": "Diazepam", "product_id": "43063-970_415f6daf-09f1-78a5-e063-6294a90a9553", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43063-970", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}