Home NDC 40028-513 Ammonia N 13
Product NDC 40028-513
11-digit product format 400280513
Labeler code 40028
Product ID 40028-513_4a821f06-a881-41f6-be44-60de3b6d83f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonia N-13
Dosage form INJECTION
Route INTRAVENOUS
Labeler PETNET Solutions, Inc.
Application ANDA204510
Marketing category ANDA
Marketing start 2007-08-23
Marketing end 0000-00-00
Substance AMMONIA N-13
Active strength 38 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40028-513-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40028-513-30 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204510-001 AMMONIA N 13 AMMONIA N-13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204510-001 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 · 42 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 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204510-001 AMMONIA N 13 30mCi-300mCi (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2015-11-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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 40028-513-30 40028051330 30 mL in 1 VIAL, GLASS (40028-513-30) 30 ml 2007-08-23 0000-00-00 No No Current