Home NDC 71162-001-05 Ammonia N 13
Product NDC 71162-001
Requested package NDC 71162-001-05
11-digit product format 711620001
Labeler code 71162
Product ID 71162-001_4e05ea57-15bf-4f09-e063-6294a90a1c2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonia N-13
Dosage form INJECTION
Route INTRAVENOUS
Labeler Ionetix Corporation
Application ANDA210524
Marketing category ANDA
Marketing start 2018-12-21
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 1 .
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 A210524-001 AMMONIA N 13 AMMONIA N-13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210524-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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
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 71162-001-05 Ammonia N 13 5 mL in 1 SYRINGE, PLASTIC INJECTION 5 17 71162-001-10 Ammonia N 13 10 mL in 1 VIAL, GLASS INJECTION 10 17 71162-001-10 Ammonia N 13 1 in 1 CONTAINER INJECTION 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71162-001 AMMONIA N 13 (AMMONIA N-13) INJECTION [IONETIX CORPORATION] 15 Current NDC, Legacy NDC, 3 package rows 20241023_61e196ba-3812-4ffd-8032-12b215378fef.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 71162-001-05 71162000105 5 mL in 1 SYRINGE, PLASTIC (71162-001-05) 5 ml 2020-01-31 0000-00-00 No No Current