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 55289-092
Product ID 55289-092_4199c273-a07c-ebb6-e063-6394a90a77a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070325
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1985-09-04

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289092
Hyphenated Format 55289-092

Supplemental Identifiers

RxCUI
197589
UPC
0355289092308
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 ANDA070325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (55289-092-01)
  • 2 TABLET in 1 BOTTLE, PLASTIC (55289-092-02)
  • 6 TABLET in 1 BOTTLE, PLASTIC (55289-092-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (55289-092-10)
  • 20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20)
  • 25 TABLET in 1 BOTTLE, PLASTIC (55289-092-25)
  • 30 TABLET in 1 BOTTLE, PLASTIC (55289-092-30)
  • 40 TABLET in 1 BOTTLE, PLASTIC (55289-092-40)
  • 60 TABLET in 1 BOTTLE, PLASTIC (55289-092-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (55289-092-90)
  • 120 TABLET in 1 BOTTLE, PLASTIC (55289-092-98)
source: ndc

Packages (11)

55289-092-01 100 TABLET in 1 BOTTLE, PLASTIC (55289-092-01) 55289-092-02 2 TABLET in 1 BOTTLE, PLASTIC (55289-092-02) 55289-092-06 6 TABLET in 1 BOTTLE, PLASTIC (55289-092-06) 55289-092-10 10 TABLET in 1 BOTTLE, PLASTIC (55289-092-10) 55289-092-20 20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20) 55289-092-25 25 TABLET in 1 BOTTLE, PLASTIC (55289-092-25) 55289-092-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-092-30) 55289-092-40 40 TABLET in 1 BOTTLE, PLASTIC (55289-092-40) 55289-092-60 60 TABLET in 1 BOTTLE, PLASTIC (55289-092-60) 55289-092-90 90 TABLET in 1 BOTTLE, PLASTIC (55289-092-90) 55289-092-98 120 TABLET in 1 BOTTLE, PLASTIC (55289-092-98)

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": "4199c273-a07c-ebb6-e063-6394a90a77a0", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0355289092308"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589"], "spl_set_id": ["c2768add-5e01-4ff4-afa3-230380d59a1f"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (55289-092-01)", "package_ndc": "55289-092-01", "marketing_start_date": "20100101"}, {"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (55289-092-02)", "package_ndc": "55289-092-02", "marketing_start_date": "20100101"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (55289-092-06)", "package_ndc": "55289-092-06", "marketing_start_date": "20100101"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (55289-092-10)", "package_ndc": "55289-092-10", "marketing_start_date": "20100101"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20)", "package_ndc": "55289-092-20", "marketing_start_date": "20100101"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE, PLASTIC (55289-092-25)", "package_ndc": "55289-092-25", "marketing_start_date": "20100101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (55289-092-30)", "package_ndc": "55289-092-30", "marketing_start_date": "20100101"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE, PLASTIC (55289-092-40)", "package_ndc": "55289-092-40", "marketing_start_date": "20100101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (55289-092-60)", "package_ndc": "55289-092-60", "marketing_start_date": "20100101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (55289-092-90)", "package_ndc": "55289-092-90", "marketing_start_date": "20100101"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (55289-092-98)", "package_ndc": "55289-092-98", "marketing_start_date": "20100101"}], "brand_name": "Diazepam", "product_id": "55289-092_4199c273-a07c-ebb6-e063-6394a90a77a0", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "55289-092", "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": "ANDA070325", "marketing_category": "ANDA", "marketing_start_date": "19850904", "listing_expiration_date": "20261231"}