diazepam

Generic: diazepam oral

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam oral
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diazepam 5 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-767
Product ID 68999-767_433f5cb2-eae0-c144-e063-6294a90a9cd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206477
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999767
Hyphenated Format 68999-767

Supplemental Identifiers

RxCUI
309843
UNII
Q3JTX2Q7TU
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 oral (source: ndc)
Application Number ANDA206477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-767-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-767-45)
source: ndc

Packages (1)

68999-767-24 2 TRAY in 1 BOX (68999-767-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-767-45)

Ingredients (1)

diazepam (5 mg/5mL)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "433f5cb2-eae0-c144-e063-6294a90a9cd9", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309843"], "spl_set_id": ["167ee280-be68-4a28-a7d8-de41df14bc48"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-767-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-767-45)", "package_ndc": "68999-767-24", "marketing_start_date": "20251029"}], "brand_name": "Diazepam", "product_id": "68999-767_433f5cb2-eae0-c144-e063-6294a90a9cd9", "dosage_form": "SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68999-767", "dea_schedule": "CIV", "generic_name": "Diazepam Oral", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/5mL"}], "application_number": "ANDA206477", "marketing_category": "ANDA", "marketing_start_date": "20160624", "listing_expiration_date": "20261231"}