MedPath

Ampicillin

Ampicillin Capsules, USP

Approved
Approval ID

3b49ec7f-e511-4d98-857b-94a006027792

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 5, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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

Ampicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-3113
Application NumberANDA064082
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2012
FDA Product Classification

INGREDIENTS (12)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMPICILLIN TRIHYDRATEActive
Quantity: 500 mg in 1 1
Code: HXQ6A1N7R6
Classification: ACTIM

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Ampicillin - FDA Drug Approval Details