Lincomycin

Product NDC
0121-1035
11-digit product format
001211035
Labeler code
0121
Product ID
0121-1035_23f95ea6-ad32-a143-e063-6394a90ae77c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lincomycin Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA212770
Marketing category
ANDA
Marketing start
2024-10-07
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1035-55Lincomycin10 mL in 1 VIAL, MULTI-DOSEINJECTION101
0121-1035-55Lincomycin10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1035-55ML - Milliliter0121-10359e1c4c33-1434-4535-99c8-666720ed2dd012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1035LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION [PAI HOLDINGS, LLC DBA PAI PHARMA]1Current NDC, 2 package rows20241010_23f9608c-3126-35db-e063-6294a90af054.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239212lincomycin 300 MG/ML Injectable SolutionPSN23f9608c-3126-35db-e063-6294a90af0541
239212lincomycin 300 MG/ML Injectable SolutionSCD23f9608c-3126-35db-e063-6294a90af0541
239212lincomycin (as lincomycin HCl) 300 MG/ML Injectable SolutionSY23f9608c-3126-35db-e063-6294a90af0541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0121-1035-550012110355510 VIAL, MULTI-DOSE in 1 CARTON (0121-1035-55) / 10 mL in 1 VIAL, MULTI-DOSE2024-10-07NoNoCurrent