Basic Information
ESOMEPRAZOLE MAGNESIUM D/R
61919-834
Regulatory Information
61919-834
ANDA078279
C73584
October 20, 2015
USA
ESOMEPRAZOLE MAGNESIUM
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
079254320
Active Ingredients
D&C Red No. 28
Code: 767IP0Y5NH
Class Code: IACT
Gelatin
Code: 2G86QN327L
Class Code: IACT
Ammonia
Code: 5138Q19F1X
Class Code: IACT
Potassium Hydroxide
Code: WZH3C48M4T
Class Code: IACT
Propylene Glycol
Code: 6DC9Q167V3
Class Code: IACT
Isopropyl Alcohol
Code: ND2M416302
Class Code: IACT
Shellac
Code: 46N107B71O
Class Code: IACT
Glyceryl Monostearate
Code: 230OU9XXE4
Class Code: IACT
Hypromelloses
Code: 3NXW29V3WO
Class Code: IACT
Magnesium Stearate
Code: 70097M6I30
Class Code: IACT
Methacrylic Acid
Code: 1CS02G8656
Class Code: IACT
Polysorbate 80
Code: 6OZP39ZG8H
Class Code: IACT
Talc
Code: 7SEV7J4R1U
Class Code: IACT
Triethyl Citrate
Code: 8Z96QXD6UM
Class Code: IACT
Fd&C Blue No. 1
Code: H3R47K3TBD
Class Code: IACT
Titanium Dioxide
Code: 15FIX9V2JP
Class Code: IACT
Ferrosoferric Oxide
Code: XM0M87F357
Class Code: IACT
Butyl Alcohol
Code: 8PJ61P6TS3
Class Code: IACT
Alcohol
Code: 3K9958V90M
Class Code: IACT
Hydroxypropyl Cellulose (Type H)
Code: RFW2ET671P
Class Code: IACT
Active Moieties
ESOMEPRAZOLE
Code: N3PA6559FT