Home DailyMed 13fda3ea-1cf5-4d32-9cba-4f8282098cea National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-04-01
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:03:31 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018511-001 DRAXIMAGE DTPA TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018511-001 AP
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 · 43 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 2026-09-14 22:38:34 2026-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DRAXIMAGE DTPA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE Jubilant DraxImage Inc., dba Jubilant Radiopharma becdab53-f7a7-7280-6930-21f3a61b99e7 2023-05-08 Warnings, Adverse reactions Exact identifier ndc (package): 65174-288-30 ndc11 (package): 65174028830
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.