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FDA Approval

Acamprosate Calcium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 17, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acamprosate(333 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acamprosate Calcium

Product Details

NDC Product Code
0378-6333
Application Number
ANDA200142
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 19, 2014
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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