Labetalol Hydrochloride
Labetalol Hydrochloride Tablets, USP 8443901/0119 Rx only
Approved
Approval ID
3004aa59-288c-4971-b77b-78789715ef5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-439
Application NumberANDA207743
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LABETALOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-461
Application NumberANDA207743
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LABETALOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-450
Application NumberANDA207743
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LABETALOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT