FDA.reportPublic FDA data

Lincomycin

Product NDC
39822-0350
11-digit product format
398220350
Labeler code
39822
Product ID
39822-0350_df369d62-f1a4-1a53-e053-2995a90abbf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lincomycin hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA201746
Marketing category
ANDA
Marketing start
2015-07-05
Substance
LINCOMYCIN HYDROCHLORIDE
Active strength
300 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lincomycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINCOMYCIN HYDROCHLORIDE300 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6T05Z2B68
Rxcui239212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
673b6365-42b3-455d-b9d1-7358f1db4536Product name420231212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0350-1Lincomycin2 mL in 1 VIALINJECTION, SOLUTION29
39822-0350-2Lincomycin10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0350-1ML - Milliliter39822-035022ad1a2b-326e-40c7-badc-47589f0213b912016-02-04
39822-0350-2ML - Milliliter39822-0350b8f2a8f6-892d-45e6-bd2f-a36c32e88a6012016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINCOMYCIN HYDROCHLORIDEACTIVE INGREDIENTM6T05Z2B68LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]4
LINCOMYCINACTIVE MOIETYBOD072YW0FLINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0350LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]9Current NDC, Legacy NDC, 2 package rows20221018_61f4851d-d919-400d-912a-05eb9dca11d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239212lincomycin 300 MG/ML Injectable SolutionPSN61f4851d-d919-400d-912a-05eb9dca11d49
239212lincomycin 300 MG/ML Injectable SolutionSCD61f4851d-d919-400d-912a-05eb9dca11d49
239212lincomycin (as lincomycin HCl) 300 MG/ML Injectable SolutionSY61f4851d-d919-400d-912a-05eb9dca11d49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0350-1398220350012 mL in 1 VIAL2 mlHistorical
39822-0350-23982203500210 VIAL in 1 CARTON (39822-0350-2) / 2 mL in 1 VIAL (39822-0350-1) 10 vial2015-07-050000-00-00NoNoCurrent