NDC 54868-4903 - Labetalol Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54868-4903
Package NDCs from labels
54868-4903-0, 54868-4903-1, 54868-4903-2
Manufacturer
Physicians Total Care, Inc.
Effective date
2012-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-04-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4903-0Labetalol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
54868-4903-1Labetalol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
54868-4903-2Labetalol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4903LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]33 package rows20120404_01735685-40e0-4323-af5a-91db399f6451.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-4903-0EA - Each54868-49030574f13d-88d8-43d8-8763-ff3f49bc9c1712012-07-24
54868-4903-1EA - Each54868-49033b306704-0e55-4203-a663-142f8cbb502212012-07-24
54868-4903-2EA - Each54868-490363b57013-e94f-4162-8ac0-788e8cc855b712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3