FDA.reportPublic FDA data

TechneLite

Product NDC
11994-091
11-digit product format
119940091
Labeler code
11994
Product ID
11994-091_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
11994-091-01TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-01TechneLite12 mL in 1 VIALINJECTION, SOLUTION1217
11994-091-03TechneLite16 mL in 1 VIALINJECTION, SOLUTION1617
11994-091-03TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-04TechneLite18 mL in 1 VIALINJECTION, SOLUTION1817
11994-091-04TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-05TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-05TechneLite20 mL in 1 VIALINJECTION, SOLUTION2017
11994-091-06TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-06TechneLite24 mL in 1 VIALINJECTION, SOLUTION2417
11994-091-07TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-07TechneLite30 mL in 1 VIALINJECTION, SOLUTION3017
11994-091-09TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-09TechneLite40 mL in 1 VIALINJECTION, SOLUTION4017
11994-091-10TechneLite50 mL in 1 VIALINJECTION, SOLUTION5017
11994-091-10TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-11TechneLite60 mL in 1 VIALINJECTION, SOLUTION6017
11994-091-11TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-12TechneLite72 mL in 1 VIALINJECTION, SOLUTION7217
11994-091-12TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-13TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-13TechneLite80 mL in 1 VIALINJECTION, SOLUTION8017
11994-091-36TechneLite4 mL in 1 VIALINJECTION, SOLUTION417
11994-091-36TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-73TechneLite1 in 1 CARTONINJECTION, SOLUTION117
11994-091-73TechneLite8 mL in 1 VIALINJECTION, SOLUTION817
11994-091-92TechneLite10 mL in 1 VIALINJECTION, SOLUTION1017
11994-091-92TechneLite1 in 1 CARTONINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11994-091-01EA - Each11994-09173050724-c62d-401a-97ce-73e2e0ee1b8a12023-02-06
11994-091-03EA - Each11994-091b53778e1-c4a0-41e0-b1b2-3c0a11a318a512023-02-06
11994-091-04EA - Each11994-091e9da5661-1e8e-4424-b367-346ebc54ee0512023-02-06
11994-091-05EA - Each11994-091daffb74e-05e4-4a2c-8920-fbed1c5aebf512023-02-06
11994-091-06EA - Each11994-091f0611be2-7ac1-4fad-a8de-0c13bc89d13f12023-02-06
11994-091-07EA - Each11994-09182ce14af-7903-4377-b244-c425d09a119412023-02-06
11994-091-09EA - Each11994-091da26d2da-cb18-4f1c-b6b0-00459f51645b12023-02-06
11994-091-10EA - Each11994-0916491621b-4f4a-430b-a3d2-dfd4c490cfdd12023-02-06
11994-091-11EA - Each11994-091b8a83a7d-89d2-467f-8307-793ae7fba10a12023-02-06
11994-091-12EA - Each11994-0917fb948e3-7ae7-4f80-9249-2fb70937b01812023-02-06
11994-091-36EA - Each11994-09109870c6a-36d2-4fd7-a0b4-03231da537f912023-02-06
11994-091-73EA - Each11994-091a0419e69-db05-4741-bd58-42cd697fc12912023-02-06
11994-091-92EA - Each11994-091562b6a9f-4a1a-42b7-a4b6-88bfbf1f75ea12023-02-06

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
11994-091TECHNELITE (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
11994-091-01119940091011 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-03119940091031 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-04119940091041 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-05119940091051 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-06119940091061 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-07119940091071 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-09119940091091 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-10119940091101 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-11119940091111 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-12119940091121 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-13119940091131 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-36119940091361 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-73119940091731 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent
11994-091-92119940091921 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL1 vial2010-09-280000-00-00NoNoCurrent