Home NDC 75913-113 Ammonia N 13
Product NDC 75913-113
11-digit product format 759130113
Labeler code 75913
Product ID 75913-113_2e49b8b5-9218-4e09-98e5-e2bd98397308
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NH3N13
Dosage form INJECTION
Route INTRAVENOUS
Labeler Washington University School of Medicine
Application ANDA204506
Marketing category ANDA
Marketing start 2012-03-20
Substance AMMONIA N-13
Active strength 37.5 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A204506-001 AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 A204506-002 AMMONIA N 13 AMMONIA N-13 37.5mCi-800mCi/10ML (3.75-80mCi/ML) INJECTABLE / INTRAVENOUS RS 2026-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204506-001 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 · 48 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 2026-10-15 13:18:30 2026-09 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204506-002 AMMONIA N 13 37.5mCi-800mCi/10ML (3.75-80mCi/ML) INJECTABLE / INTRAVENOUS RS 2026-02-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204506-002 AMMONIA N 13 37.5mCi-800mCi/10ML (3.75-80mCi/ML) INJECTABLE / INTRAVENOUS RS 2026-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204506-002 AMMONIA N 13 37.5mCi-800mCi/10ML (3.75-80mCi/ML) INJECTABLE / INTRAVENOUS RS 2026-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204506-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2014-02-07 3f0d92c62455…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A204506-001 AP 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204506-001 AP 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204506-001 AP 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204506-001 AP 1 a50c72e98297…
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 Ammonia N 13
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMONIA N-13 37.5 mCi/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75913-113-10 Ammonia N 13 10 mL in 1 VIAL, GLASS INJECTION 10 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75913-113 AMMONIA N 13 (NH3N13) INJECTION [WASHINGTON UNIVERSITY SCHOOL OF MEDICINE] 9 Current NDC, Legacy NDC, 1 package rows 20211030_611f4a03-5b6f-420a-925e-adb905bf7b51.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 75913-113-10 75913011310 10 mL in 1 VIAL, GLASS (75913-113-10) 10 ml 2012-03-20 0000-00-00 No No Current