Home NDC 49609-003-01 Ammonia
Product NDC 49609-003
Requested package NDC 49609-003-01
11-digit product format 496090003
Labeler code 49609
Product ID 49609-003_5e5d1fbb-d12d-4034-e063-6294a90a336c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMMONIA N-13
Dosage form INJECTION
Route INTRAVENOUS
Labeler SOFIE Co. dba SOFIE
Application ANDA203543
Marketing category ANDA
Marketing start 2011-08-04
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 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 A203543-001 AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203543-001 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 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203543-001 AMMONIA N 13 3.75-260mCi/ML INJECTABLE / INTRAVENOUS 2012-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203543-001 AMMONIA N 13 3.75-260mCi/ML INJECTABLE / INTRAVENOUS 2012-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203543-001 AMMONIA N 13 3.75-260mCi/ML INJECTABLE / INTRAVENOUS 2012-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203543-001 AMMONIA N 13 3.75-260mCi/ML INJECTABLE / INTRAVENOUS 2012-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203543-001 AMMONIA N 13 3.75-260mCi/ML INJECTABLE / INTRAVENOUS 2012-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203543-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP RS 2012-12-14 3a93d1ddd44b…
Observed Orange Book normalized TE history# 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
Brand name suffix N 13
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49609-003-01 AmmoniaN 13 30 mL in 1 VIAL, GLASS INJECTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49609-003 AMMONIA N 13 (AMMONIA N-13) INJECTION [SOFIE CO. DBA SOFIE] 3 Current NDC, Legacy NDC, 1 package rows 20250406_85882893-0661-46c2-a5f2-a73f6ea4fb5a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49609-003-01 49609000301 30 mL in 1 VIAL, GLASS (49609-003-01) 30 ml 2011-08-04 0000-00-00 No No Current