Home NDC 11994-091 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017771-001 TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 N017771-002 TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017771-001 TECHNELITE 0.0083-2.7 CI/GENERATOR SOLUTION / INTRAVENOUS Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017771-002 TECHNELITE 1-20 CI/GENERATOR SOLUTION / INTRAVENOUS RLD, RS 2014-02-12 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base TechneLite
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M SODIUM PERTECHNETATE 250 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A0730CX801 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11994-091-01 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-01 TechneLite 12 mL in 1 VIAL INJECTION, SOLUTION 12 17 11994-091-03 TechneLite 16 mL in 1 VIAL INJECTION, SOLUTION 16 17 11994-091-03 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-04 TechneLite 18 mL in 1 VIAL INJECTION, SOLUTION 18 17 11994-091-04 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-05 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-05 TechneLite 20 mL in 1 VIAL INJECTION, SOLUTION 20 17 11994-091-06 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-06 TechneLite 24 mL in 1 VIAL INJECTION, SOLUTION 24 17 11994-091-07 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-07 TechneLite 30 mL in 1 VIAL INJECTION, SOLUTION 30 17 11994-091-09 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-09 TechneLite 40 mL in 1 VIAL INJECTION, SOLUTION 40 17 11994-091-10 TechneLite 50 mL in 1 VIAL INJECTION, SOLUTION 50 17 11994-091-10 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-11 TechneLite 60 mL in 1 VIAL INJECTION, SOLUTION 60 17 11994-091-11 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-12 TechneLite 72 mL in 1 VIAL INJECTION, SOLUTION 72 17 11994-091-12 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-13 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-13 TechneLite 80 mL in 1 VIAL INJECTION, SOLUTION 80 17 11994-091-36 TechneLite 4 mL in 1 VIAL INJECTION, SOLUTION 4 17 11994-091-36 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-73 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17 11994-091-73 TechneLite 8 mL in 1 VIAL INJECTION, SOLUTION 8 17 11994-091-92 TechneLite 10 mL in 1 VIAL INJECTION, SOLUTION 10 17 11994-091-92 TechneLite 1 in 1 CARTON INJECTION, SOLUTION 1 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11994-091 TECHNELITE (TECHNETIUM TC99M GENERATOR) INJECTION, SOLUTION [LANTHEUS MEDICAL IMAGING, INC.] 17 Current NDC, Legacy NDC, 28 package rows 20241106_3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11994-091-01 11994009101 1 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-03 11994009103 1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-04 11994009104 1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-05 11994009105 1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-06 11994009106 1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-07 11994009107 1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-09 11994009109 1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-10 11994009110 1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-11 11994009111 1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-12 11994009112 1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-13 11994009113 1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-36 11994009136 1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-73 11994009173 1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current 11994-091-92 11994009192 1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL 1 vial 2010-09-28 0000-00-00 No No Current