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 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-987
Product ID 43063-987_415f8162-1d01-9092-e063-6394a90ace01
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 43063987
Hyphenated Format 43063-987

Supplemental Identifiers

RxCUI
197589
UPC
0343063987605
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
  • 2 TABLET in 1 BOTTLE, PLASTIC (43063-987-02)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-987-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-987-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-987-60)
source: ndc

Packages (4)

43063-987-02 2 TABLET in 1 BOTTLE, PLASTIC (43063-987-02) 43063-987-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-987-20) 43063-987-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-987-30) 43063-987-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-987-60)

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": "415f8162-1d01-9092-e063-6394a90ace01", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0343063987605"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589"], "spl_set_id": ["84cecab3-d0e6-436b-996b-0b598e972308"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (43063-987-02)", "package_ndc": "43063-987-02", "marketing_start_date": "20200923"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-987-20)", "package_ndc": "43063-987-20", "marketing_start_date": "20200523"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-987-30)", "package_ndc": "43063-987-30", "marketing_start_date": "20200530"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-987-60)", "package_ndc": "43063-987-60", "marketing_start_date": "20200530"}], "brand_name": "Diazepam", "product_id": "43063-987_415f8162-1d01-9092-e063-6394a90ace01", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43063-987", "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": "10 mg/1"}], "application_number": "ANDA071322", "marketing_category": "ANDA", "marketing_start_date": "19861210", "listing_expiration_date": "20261231"}