Home NDC 13267-456 Ammonia N 13
Product NDC 13267-456
11-digit product format 132670456
Labeler code 13267
Product ID 13267-456_0bd46b33-99e9-4989-8816-182d7d72babb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NH3N13
Dosage form INJECTION
Route INTRAVENOUS
Labeler THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Application NDA022119
Marketing category NDA
Marketing start 2007-08-23
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 2026-12-31
Current FDA listing Yes 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 N022119-001 AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022119-001 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 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022119-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2007-08-23 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 N 13
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13267-456-56 Ammonia N 13 8 mL in 1 VIAL, GLASS INJECTION 8 20191030
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13267-456 AMMONIA N 13 (NH3N13) INJECTION [THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH] 20191030 Current NDC, Legacy NDC, 1 package rows 20191106_c857724f-b172-4844-ad42-6fa4c42b0405.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 13267-456-56 13267045656 8 mL in 1 VIAL, GLASS (13267-456-56) 8 ml 2007-08-23 0000-00-00 No No Current