TechneLite
- Product NDC
- 87333-090
- 11-digit product format
- 873330090
- Labeler code
- 87333
- Product ID
- 87333-090_d4854be6-0d3a-4f5d-bd7c-4ab467cc1abc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Technetium Tc99m Generator
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- SHINE SPECT USA, LLC
- Application
- NDA017771
- Marketing category
- NDA
- Marketing start
- 2026-10-21
- Substance
- TECHNETIUM TC-99M SODIUM PERTECHNETATE
- Active strength
- 250 mCi/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N017771-001 | TECHNELITE | 0.0083-2.7 CI/GENERATOR | SOLUTION / INTRAVENOUS | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N017771-002 | TECHNELITE | 1-20 CI/GENERATOR | SOLUTION / INTRAVENOUS | RLD, RS | 2014-02-12 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N017771-001 | TECHNELITE | 0.0083-2.7 CI/GENERATOR | SOLUTION / INTRAVENOUS | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017771-002 | TECHNELITE | 1-20 CI/GENERATOR | SOLUTION / INTRAVENOUS | RLD, RS | 2014-02-12 | 84e616aacf4f… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TechneLite
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TECHNETIUM TC-99M SODIUM PERTECHNETATE | 250 mCi/mL |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TechneLite | TECHNETIUM TC99M GENERATOR | Lantheus Medical Imaging, Inc. | 3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4 | 2024-11-01 | Warnings, Adverse reactions | 017771 NDA017771 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87333-090-01 | 87333009001 | 1 VIAL in 1 CARTON (87333-090-01) / 12 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-03 | 87333009003 | 1 VIAL in 1 CARTON (87333-090-03) / 16 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-04 | 87333009004 | 1 VIAL in 1 CARTON (87333-090-04) / 18 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-05 | 87333009005 | 1 VIAL in 1 CARTON (87333-090-05) / 20 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-06 | 87333009006 | 1 VIAL in 1 CARTON (87333-090-06) / 24 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-07 | 87333009007 | 1 VIAL in 1 CARTON (87333-090-07) / 30 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-09 | 87333009009 | 1 VIAL in 1 CARTON (87333-090-09) / 40 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-10 | 87333009010 | 1 VIAL in 1 CARTON (87333-090-10) / 50 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-11 | 87333009011 | 1 VIAL in 1 CARTON (87333-090-11) / 60 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-12 | 87333009012 | 1 VIAL in 1 CARTON (87333-090-12) / 72 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-13 | 87333009013 | 1 VIAL in 1 CARTON (87333-090-13) / 80 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-36 | 87333009036 | 1 VIAL in 1 CARTON (87333-090-36) / 4 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-73 | 87333009073 | 1 VIAL in 1 CARTON (87333-090-73) / 8 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |
| 87333-090-92 | 87333009092 | 1 VIAL in 1 CARTON (87333-090-92) / 10 mL in 1 VIAL | 1 vial | 2026-10-21 | No | No | Current |