Home NDC 69714-001 Ammonia N 13
Product NDC 69714-001
11-digit product format 697140001
Labeler code 69714
Product ID 69714-001_d25fad57-4b86-4265-96e6-40521006d7f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NH3N13
Dosage form INJECTION
Route INTRAVENOUS
Labeler University of Alabama at Birmingham
Application ANDA211698
Marketing category ANDA
Marketing start 2018-10-01
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 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 A211698-001 AMMONIA N 13 AMMONIA N-13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211698-001 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.
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 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211698-001 AMMONIA N 13 15mCi-150mCi/4ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2022-11-03 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69714-001-10 Ammonia N 13 10 mL in 1 VIAL, GLASS INJECTION 10 7 69714-001-10 Ammonia N 13 1 in 1 CONTAINER INJECTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69714-001 AMMONIA N 13 (NH3N13) INJECTION [UNIVERSITY OF ALABAMA AT BIRMINGHAM] 6 Legacy NDC, 2 package rows 20241023_bbc03271-8d23-4e89-aa32-cff581cdc275.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69714-001-01 69714000101 4 mL in 1 VIAL, GLASS (69714-001-01) 4 ml 2018-10-01 0000-00-00 No No Current 69714-001-10 69714000110 10 mL in 1 VIAL, GLASS 10 ml Historical