FDA.reportPublic FDA data

Lincomycin

Product NDC
72485-115
11-digit product format
724850115
Labeler code
72485
Product ID
72485-115_2b18b782-a0a7-4072-b573-e66de82eae06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lincomycin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA215082
Marketing category
ANDA
Marketing start
2023-05-05
Substance
LINCOMYCIN HYDROCHLORIDE
Active strength
3000 mg/10mL
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 HYDROCHLORIDE3000 mg/10mL

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
72485-115-01Lincomycin10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
72485-115-10Lincomycin10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-115-01ML - Milliliter72485-1158c6bd75a-1545-40b5-801d-054a5c4681fb12023-06-06
72485-115-10ML - Milliliter72485-1158eaf50ad-fb18-47f0-a5d5-dd31419da46a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-115LINCOMYCIN (LINCOMYCIN) INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230520_ebabccf4-f082-4fc0-9223-f4826dc89b13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239212lincomycin 300 MG/ML Injectable SolutionPSNebabccf4-f082-4fc0-9223-f4826dc89b131
239212lincomycin 300 MG/ML Injectable SolutionSCDebabccf4-f082-4fc0-9223-f4826dc89b131
239212lincomycin (as lincomycin HCl) 300 MG/ML Injectable SolutionSYebabccf4-f082-4fc0-9223-f4826dc89b131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-115-017248501150110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
72485-115-107248501151010 VIAL, MULTI-DOSE in 1 CARTON (72485-115-10) / 10 mL in 1 VIAL, MULTI-DOSE (72485-115-01) 2023-05-05NoNoHistorical