Home NDC 69864-002 Ammonia N-13
Product NDC 69864-002
11-digit product format 698640002
Labeler code 69864
Product ID 69864-002_0ce4c7b6-2913-fecf-e063-6394a90ab438
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonia N-13
Dosage form INJECTION
Route INTRAVENOUS
Labeler The Methodist Hospital Research Institute
Application ANDA215083
Marketing category ANDA
Marketing start 2021-07-09
Substance AMMONIA N-13
Active strength 260 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 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 A215083-001 AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215083-001 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 2026-02-19 14:30 UTC 2026-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a50c72e98297…
Observed Orange Book normalized TE history# 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-13 260 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69864-002-30 Ammonia N-13 6 mL in 1 VIAL, GLASS INJECTION 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69864-002 AMMONIA N-13 INJECTION [THE METHODIST HOSPITAL RESEARCH INSTITUTE] 2 Current NDC, Legacy NDC, 1 package rows 20231227_c79222b1-7dd8-f1fe-e053-2a95a90a3639.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 69864-002-30 69864000230 6 mL in 1 VIAL, GLASS (69864-002-30) 6 ml 2021-07-09 0000-00-00 No No Current