FDA.reportPublic FDA data

TechneLite

Product NDC
11994-090
11-digit product format
119940090
Labeler code
11994
Product ID
11994-090_ffbbca75-06da-47fc-bc12-ceefdf308162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc99m Generator
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Lantheus Medical Imaging, Inc.
Application
NDA017771
Marketing category
NDA
Marketing start
1975-11-01
Substance
TECHNETIUM TC-99M SODIUM PERTECHNETATE
Active strength
250 mCi/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECHNETIUM TC-99M SODIUM PERTECHNETATE250 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0730CX801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11994-090-01TechneLite12 mL in 1 VIALINJECTION, SOLUTION1217
11994-090-01TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-03TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-03TechneLite16 mL in 1 VIALINJECTION, SOLUTION1617
11994-090-04TechneLite18 mL in 1 VIALINJECTION, SOLUTION1817
11994-090-04TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-05TechneLite20 mL in 1 VIALINJECTION, SOLUTION2017
11994-090-05TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-06TechneLite24 mL in 1 VIALINJECTION, SOLUTION2417
11994-090-06TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-07TechneLite30 mL in 1 VIALINJECTION, SOLUTION3017
11994-090-07TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-09TechneLite40 mL in 1 VIALINJECTION, SOLUTION4017
11994-090-09TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-10TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-10TechneLite50 mL in 1 VIALINJECTION, SOLUTION5017
11994-090-11TechneLite60 mL in 1 VIALINJECTION, SOLUTION6017
11994-090-11TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-12TechneLite72 mL in 1 VIALINJECTION, SOLUTION7217
11994-090-12TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-13TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-13TechneLite80 mL in 1 VIALINJECTION, SOLUTION8017
11994-090-36TechneLite4 mL in 1 VIALINJECTION, SOLUTION417
11994-090-36TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-73TechneLite8 mL in 1 VIALINJECTION, SOLUTION817
11994-090-73TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-92TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-090-92TechneLite10 mL in 1 VIALINJECTION, SOLUTION1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11994-090-01EA - Each11994-090becb9d02-382c-4933-b277-ab1706adc89412019-10-07
11994-090-03EA - Each11994-09057e17dae-19bf-4db7-8105-cae660a8bac612023-02-06
11994-090-04EA - Each11994-090c5d8f232-3a77-4495-8138-def73bfb10ca12023-02-06
11994-090-05EA - Each11994-090465a4733-57ca-4ab7-ad3b-31c3a8f579f012023-02-06
11994-090-06EA - Each11994-09080661d23-40e9-4b30-8b48-4258ffbcae7912023-02-06
11994-090-07EA - Each11994-090d4886a1b-c425-4fcc-b7c7-6c0f82448ec512023-02-06
11994-090-09EA - Each11994-090ce197760-5c9a-4bae-91c5-8c0ae579ccef12023-02-06
11994-090-10EA - Each11994-0908fc66197-a3c9-4656-824d-63387a00328c12023-02-06
11994-090-11EA - Each11994-0901f6a6de9-e6ad-4759-b4a8-6e6b75d71efb12023-02-06
11994-090-12EA - Each11994-0909a71faaf-78ac-40ff-88d5-3ef44b979e8612023-02-06
11994-090-36EA - Each11994-090beab41d5-75b9-48bb-9ca7-a2049c3e0e1212019-06-19
11994-090-73EA - Each11994-090be08220e-ee5d-4332-810a-a4cb64f6ab3b12023-02-06
11994-090-92EA - Each11994-0907c3da15f-569e-4e7a-babe-c1c1107b071f12023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TECHNETIUM TC-99M SODIUM PERTECHNETATEACTIVE INGREDIENTA0730CX801TECHNELITE (TECHNETIUM TC99M GENERATOR) INJECTION, SOLUTION [LANTHEUS MEDICAL IMAGING, INC.]9
TECHNETIUM TC-99M PERTECHNETATEACTIVE MOIETYPPP8783IQ1TECHNELITE (TECHNETIUM TC99M GENERATOR) INJECTION, SOLUTION [LANTHEUS MEDICAL IMAGING, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11994-090TECHNELITE (TECHNETIUM TC99M GENERATOR) INJECTION, SOLUTION [LANTHEUS MEDICAL IMAGING, INC.]17Current NDC, Legacy NDC, 28 package rows20241106_3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11994-090-01119940090011 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-03119940090031 VIAL in 1 CARTON (11994-090-03) / 16 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-04119940090041 VIAL in 1 CARTON (11994-090-04) / 18 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-05119940090051 VIAL in 1 CARTON (11994-090-05) / 20 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-06119940090061 VIAL in 1 CARTON (11994-090-06) / 24 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-07119940090071 VIAL in 1 CARTON (11994-090-07) / 30 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-09119940090091 VIAL in 1 CARTON (11994-090-09) / 40 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-10119940090101 VIAL in 1 CARTON (11994-090-10) / 50 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-11119940090111 VIAL in 1 CARTON (11994-090-11) / 60 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-12119940090121 VIAL in 1 CARTON (11994-090-12) / 72 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-13119940090131 VIAL in 1 CARTON (11994-090-13) / 80 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-36119940090361 VIAL in 1 CARTON (11994-090-36) / 4 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-73119940090731 VIAL in 1 CARTON (11994-090-73) / 8 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent
11994-090-92119940090921 VIAL in 1 CARTON (11994-090-92) / 10 mL in 1 VIAL1 vial1975-11-010000-00-00NoNoCurrent