Carboprost Tromethamine
Carboprost Tromethamine Injection, USP Package Insert
Approved
Approval ID
f0b2d3f9-859a-47bb-866c-082717d1f190
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2022
Manufacturers
FDA
Long Grove Pharmaceuticals, LLC
DUNS: 081134465
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carboprost Tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81298-5010
Application NumberANDA214499
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboprost Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateOctober 19, 2022
FDA Product Classification
INGREDIENTS (6)
Carboprost TromethamineActive
Quantity: 250 ug in 1 mL
Code: U4526F86FJ
Classification: ACTIM
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
TromethamineInactive
Code: 023C2WHX2V
Classification: IACT