Levorphanol Tartrate
Levorphanol Tartrate Tablets USP, CII
Approved
Approval ID
438cf3ea-04fe-4626-9f0f-adcda7633651
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levorphanol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-762
Application NumberANDA213906
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levorphanol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEVORPHANOL TARTRATEActive
Quantity: 2 mg in 1 1
Code: 04WQU6T9QI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT