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 43 .
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 2026-09-14 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
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 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