ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM DR
Approved
Approval ID
8504300f-a584-29ed-e053-2a91aa0ad26c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2019
Manufacturers
FDA
DirectRX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESOMEPRAZOLE MAGNESIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-789
Application NumberANDA208333
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESOMEPRAZOLE MAGNESIUM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2019
FDA Product Classification
INGREDIENTS (25)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
BEETInactive
Code: N487KM8COK
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 20 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM