Technescan PYP

Product NDC
69945-094
11-digit product format
699450094
Labeler code
69945
Product ID
69945-094_45358120-83e7-a04b-e063-6394a90af91e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc 99m Pyrophosphate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Curium US LLC
Application
NDA017538
Marketing category
NDA
Marketing start
2015-10-14
Substance
SODIUM PYROPHOSPHATE; STANNOUS CHLORIDE
Active strength
11.9; 3.2 mg/10mL; mg/10mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017538-001TECHNESCAN PYP KITTECHNETIUM TC-99M PYROPHOSPHATE KITN/AINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N017538-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017538-001TECHNESCAN PYP KITN/AINJECTABLE / INJECTIONAPApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017538-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017538-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017538-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017538-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017538-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017538-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017538-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017538-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017538-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017538-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017538-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017538-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017538-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017538-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017538-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017538-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017538-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017538-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017538-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017538-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017538-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N017538-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017538-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017538-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017538-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N017538-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017538-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017538-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017538-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017538-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017538-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017538-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017538-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017538-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017538-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017538-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017538-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017538-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017538-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017538-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PYROPHOSPHATE11.9 mg/10mL
STANNOUS CHLORIDE3.2 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O352864B8ZInternal UNII lookup
1BQV3749L5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
304b63f4-a32e-4700-805d-5bc9f27e7d6aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69945-094-01Technescan PYP10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1014
69945-094-20Technescan PYP5 in 1 CELLO PACKINJECTION, POWDER, LYOPHILIZED,514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69945-094-20EA - Each69945-0941f7e5dc6-d3ca-46d8-8016-1900e6f75a9212024-05-16

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-094TECHNESCAN PYP (TECHNETIUM TC 99M PYROPHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CURIUM US LLC]10Current NDC, Legacy NDC, 2 package rows20240608_304b63f4-a32e-4700-805d-5bc9f27e7d6a.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Technescan PYPTECHNETIUM TC 99M PYROPHOSPHATECurium US LLC304b63f4-a32e-4700-805d-5bc9f27e7d6a2025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 017538
application number: NDA017538
ndc (product): 69945-094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69945-094-016994500940110 mL in 1 VIAL10 mlHistorical
69945-094-20699450094205 VIAL in 1 CELLO PACK (69945-094-20) / 10 mL in 1 VIAL (69945-094-01) 5 vial2015-10-140000-00-00NoNoCurrent