Naproxen
NAPROXEN DELAYED-RELEASE TABLETS Rx only
Approved
Approval ID
afebcc90-e2b5-416d-a041-db2dd593a648
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-343
Application NumberANDA075227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2006
FDA Product Classification
INGREDIENTS (10)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT