carboprost tromethamine

Generic: carboprost tromethamine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carboprost tromethamine
Generic Name carboprost tromethamine
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

carboprost tromethamine 250 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-584
Product ID 68083-584_ed3dacb6-5a1e-4499-bec2-5ec46a0399ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217657
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

Pharmacologic Class

Classes
prostaglandin analog [epc] prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083584
Hyphenated Format 68083-584

Supplemental Identifiers

RxCUI
238014
UNII
U4526F86FJ

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 carboprost tromethamine (source: ndc)
Generic Name carboprost tromethamine (source: ndc)
Application Number ANDA217657 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 250 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-584-10) / 1 mL in 1 VIAL
source: ndc

Packages (1)

68083-584-10 10 VIAL in 1 CARTON (68083-584-10) / 1 mL in 1 VIAL

Ingredients (1)

carboprost tromethamine (250 ug/mL)

Linked Drug Pages (1)

carboprost tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "ed3dacb6-5a1e-4499-bec2-5ec46a0399ad", "openfda": {"unii": ["U4526F86FJ"], "rxcui": ["238014"], "spl_set_id": ["5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-584-10)  / 1 mL in 1 VIAL", "package_ndc": "68083-584-10", "marketing_start_date": "20230807"}], "brand_name": "carboprost tromethamine", "product_id": "68083-584_ed3dacb6-5a1e-4499-bec2-5ec46a0399ad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "68083-584", "generic_name": "carboprost tromethamine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "carboprost tromethamine", "active_ingredients": [{"name": "CARBOPROST TROMETHAMINE", "strength": "250 ug/mL"}], "application_number": "ANDA217657", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}