Home NDC 71162-001 Ammonia N 13
Product NDC 71162-001
11-digit product format 711620001
Labeler code 71162
Product ID 71162-001_5dabc55e-1e8a-191e-e063-6394a90a654e
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 44 .
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 · 44 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 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210524-001 AMMONIA N 13 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2018-12-21 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 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
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 71162-001-10 71162000110 1 VIAL, GLASS in 1 CONTAINER (71162-001-10) > 10 mL in 1 VIAL, GLASS 2018-12-21 0000-00-00 No No Current