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Lincomycin

Lincomycin Injection, USP

Approved
Approval ID

61f4851d-d919-400d-912a-05eb9dca11d4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 14, 2022

Manufacturers
FDA

XGen Pharmaceuticals DJB, Inc.

DUNS: 117380305

Products 2

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

lincomycin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code39822-0350
Application NumberANDA201746
Product Classification
M
Marketing Category
C73584
G
Generic Name
lincomycin hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
Effective DateOctober 14, 2022
FDA Product Classification

INGREDIENTS (2)

BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
LINCOMYCIN HYDROCHLORIDEActive
Quantity: 300 mg in 1 mL
Code: M6T05Z2B68
Classification: ACTIM

lincomycin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code39822-0353
Application NumberANDA201746
Product Classification
M
Marketing Category
C73584
G
Generic Name
lincomycin hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
Effective DateOctober 14, 2022
FDA Product Classification

INGREDIENTS (2)

BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
LINCOMYCIN HYDROCHLORIDEActive
Quantity: 300 mg in 1 mL
Code: M6T05Z2B68
Classification: ACTIM

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Lincomycin - FDA Drug Approval Details