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Cephalexin

CEPHALEXIN CAPSULES, USP

Approved
Approval ID

803cdf4c-77ec-4b9b-bc2d-873eb236f9c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 26, 2010

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cephalexin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10544-617
Application NumberANDA065215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2010
FDA Product Classification

INGREDIENTS (8)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Cephalexin - FDA Drug Approval Details