diazepam

Generic: diazepam oral solution (concentrate)

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam oral solution (concentrate)
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diazepam 5 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-768
Product ID 62135-768_4517b811-0a91-89f5-e063-6294a90a9a30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204433
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135768
Hyphenated Format 62135-768

Supplemental Identifiers

RxCUI
309843 309844
UPC
0362135767242 0362135768430 0362135767471
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 solution (concentrate) (source: ndc)
Application Number ANDA204433 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (62135-768-43)
source: ndc

Packages (1)

62135-768-43 30 mL in 1 BOTTLE (62135-768-43)

Ingredients (1)

diazepam (5 mg/mL)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4517b811-0a91-89f5-e063-6294a90a9a30", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0362135767242", "0362135768430", "0362135767471"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309843", "309844"], "spl_set_id": ["cdb839fb-27e5-4a11-aed6-da0a7ab6e996"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (62135-768-43)", "package_ndc": "62135-768-43", "marketing_start_date": "20220817"}], "brand_name": "Diazepam", "product_id": "62135-768_4517b811-0a91-89f5-e063-6294a90a9a30", "dosage_form": "SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "62135-768", "dea_schedule": "CIV", "generic_name": "Diazepam Oral Solution (Concentrate)", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/mL"}], "application_number": "ANDA204433", "marketing_category": "ANDA", "marketing_start_date": "20140414", "listing_expiration_date": "20261231"}