Home NDC 62072-456 Ammonia
Product NDC 62072-456
11-digit product format 620720456
Labeler code 62072
Product ID 62072-456_bf01478c-3377-4b2c-905c-30807e865825
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMMONIA N-13
Dosage form INJECTION
Route INTRAVENOUS
Labeler Kreitchman PET Center
Application ANDA203938
Marketing category ANDA
Marketing start 2013-12-09
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 62072-456 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62072-456 62072-456-56 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A203938-001 AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203938-001 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 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203938-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-12-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ammonia
Brand name suffix N 13
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMONIA N-13 37.5 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9OQO0E343Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62072-456-56 AmmoniaN 13 8 mL in 1 VIAL, GLASS INJECTION 8 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62072-456 AMMONIA N 13 (AMMONIA N-13) INJECTION [KREITCHMAN PET CENTER] 6 Current NDC, Legacy NDC, 1 package rows 20240113_26572b37-0999-4c83-8206-1c088026d407.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 62072-456-56 62072045656 8 mL in 1 VIAL, GLASS (62072-456-56) 8 ml 2013-12-09 0000-00-00 No No Current