Labetalol Hydrochloride

LABETALOL HYDROCHLORIDE- labetalol hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1163-3

Labetalol hydrochloride tablets, 100 mg

Rx only

30 tablets

Labetalol  hydrochloride tablets
(click image for full-size original)

NDC 70771-1164-3

Labetalol hydrochloride tablets, 200 mg

Rx only

30 tablets

Labetalol  hydrochloride tablets
(click image for full-size original)

NDC 70771-1165-3

Labetalol hydrochloride tablets, 300 mg

Rx only

30 tablets

Labetalol  hydrochloride tablets
(click image for full-size original)
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape ROUND (BICONVEX) Size 8mm
Flavor Imprint Code 7;98
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1163-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1163-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1163-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1163-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (OFF-WHITE) Score 2 pieces
Shape ROUND (BICONVEX) Size 11mm
Flavor Imprint Code 7;99
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1164-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1164-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1164-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1164-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1–ALUMINUM LAKE
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (LIGHT GREEN) Score no score
Shape ROUND (BICONVEX) Size 11mm
Flavor Imprint Code 800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1165-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1165-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1165-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1165-5 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1163), ANALYSIS (70771-1164), ANALYSIS (70771-1165), MANUFACTURE (70771-1163), MANUFACTURE (70771-1164), MANUFACTURE (70771-1165)

Revised: 07/2020 Cadila Healthcare Limited

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