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Package Insert and Label Information: Labetalol HCl

By Cambrex Profarmaco Milano Srl | Last revised: 15 February 2011

LABETALOL HCL- labetalol hydrochloride powder
Cambrex Profarmaco Milano Srl

Package/Label Principal Display Panel

Labetalol HCl
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LABETALOL HCL
labetalol hydrochloride powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:12828-0070
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL 1 kg in 1 kg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12828-0070-1 25 kg in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Bulk ingredient 01/10/2011
Labeler — Cambrex Profarmaco Milano Srl (338332254)
Establishment
Name Address ID/FEI Operations
Cambrex Profarmaco Milano Srl 338332254 API MANUFACTURE

Revised: 02/2011 Cambrex Profarmaco Milano Srl