FDA.reportPublic FDA data

Lincomycin

Product NDC
25021-193
11-digit product format
250210193
Labeler code
25021
Product ID
25021-193_36277638-639e-4141-9ad0-a5afaa12043b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lincomycin Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
Labeler
Sagent Pharmaceuticals
Application
ANDA215657
Marketing category
ANDA
Marketing start
2023-04-15
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
25021-193-02Lincomycin2 mL in 1 VIALINJECTION, SOLUTION21
25021-193-02Lincomycin10 in 1 CARTONINJECTION, SOLUTION101
25021-193-10Lincomycin10 mL in 1 VIALINJECTION, SOLUTION101
25021-193-10Lincomycin10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-193-02ML - Milliliter25021-193b6b02635-6bcb-4b1b-ab5d-66834e33e83812023-10-16
25021-193-10ML - Milliliter25021-193306429b9-30ae-46da-ab29-4d157dfd9b5312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-193LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20230415_75e149cc-b668-427e-bae7-a0d215e4fb7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239212lincomycin 300 MG/ML Injectable SolutionPSN75e149cc-b668-427e-bae7-a0d215e4fb7a1
239212lincomycin 300 MG/ML Injectable SolutionSCD75e149cc-b668-427e-bae7-a0d215e4fb7a1
239212lincomycin (as lincomycin HCl) 300 MG/ML Injectable SolutionSY75e149cc-b668-427e-bae7-a0d215e4fb7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-193-022502101930210 VIAL in 1 CARTON (25021-193-02) / 2 mL in 1 VIAL10 vial2023-04-15NoNoHistorical
25021-193-102502101931010 VIAL in 1 CARTON (25021-193-10) / 10 mL in 1 VIAL10 vial2023-04-15NoNoHistorical