Ammonia

Product NDC: 76451-013
11-digit product format: 764510013
Labeler code: 76451
Product ID: 76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMMONIA N-13
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: 3D Imaging Drug Design and Development LLC
Application: ANDA203779
Marketing category: ANDA
Marketing start: 2012-01-02
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 64 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76451-013-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76451-013-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76451-013-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76451-013-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76451-013-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76451-013-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76451-013-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76451-013-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76451-013-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76451-013-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76451-013-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76451-013-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76451-013-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76451-013-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76451-013-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76451-013-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76451-013-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76451-013-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76451-013-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76451-013-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76451-013-51	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76451-013-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76451-013-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76451-013-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76451-013-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76451-013-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76451-013-51	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76451-013-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76451-013-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76451-013-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76451-013-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76451-013-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76451-013-51	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76451-013-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76451-013-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76451-013-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76451-013-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76451-013-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76451-013-51	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76451-013-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76451-013-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76451-013-51	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76451-013-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76451-013-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76451-013-51	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203779-001	AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP		2015-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203779-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203779-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2015-10-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203779-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203779-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203779-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203779-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203779-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203779-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203779-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203779-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203779-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203779-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203779-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203779-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203779-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203779-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203779-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203779-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203779-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203779-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203779-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203779-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203779-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203779-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203779-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203779-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203779-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203779-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203779-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203779-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203779-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203779-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203779-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203779-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203779-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203779-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203779-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203779-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203779-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203779-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203779-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203779-001	AP	1	`e64feba35796…`

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	37.5 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fce62c22-a1e2-4193-8de5-e1961d9b94a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b8eb56be-edf0-4b39-8ab1-e48c4aa676ef	Product name	5	20220126
76ba8fa2-294c-406c-aab2-68cb80b6d1aa	Product name	9	20210511
612e700f-023c-452e-a2e6-3ea15fd646db	Product name	1	20190416

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76451-013-10	2026-01-12	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-11	2026-01-12	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-51	2026-01-12	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-10	2023-01-30	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-11	2023-01-30	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-51	2023-01-30	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-10	2022-11-10	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-11	2022-11-10	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-51	2022-11-10	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-10	2022-07-29	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-11	2022-07-29	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X
76451-013-51	2022-07-29	These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76451-013-10	AmmoniaN 13	10 mL in 1 VIAL, GLASS	INJECTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76451-013	AMMONIA N 13 (AMMONIA N-13) INJECTION [3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190214_fce62c22-a1e2-4193-8de5-e1961d9b94a5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ammonia N 13	AMMONIA N-13	3D Imaging Drug Design and Development LLC	fce62c22-a1e2-4193-8de5-e1961d9b94a5	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203779 application number: ANDA203779 ndc (product): 76451-013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9OQO0E343Z	AMMONIA N-13	34819-78-8	AMMONIA N-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76451-013-10	76451001310	10 mL in 1 VIAL, GLASS (76451-013-10)	10 ml	2018-12-17	0000-00-00	No	No	Current
76451-013-11	76451001311	10 mL in 1 SYRINGE, PLASTIC (76451-013-11)	10 ml	2018-12-17	0000-00-00	No	No	Current
76451-013-51	76451001351	5 mL in 1 SYRINGE, PLASTIC (76451-013-51)	5 ml	2018-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ammonia N 13	3D Imaging Drug Design and Development LLC	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	3