Ammonia

Manufacturer: Kreitchman PET Center
Effective date: 2026-01-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 21:58:50

Label at a glance#

ProductAmmonia N 13

Active ingredientAMMONIA N-13

Label structure3 sections

Contacts and useful links#

PhoneLabel contact212-305-0081

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

SPL UNCLASSIFIED SECTION

Manufactured by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032

Distributed by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AMMONIA N-13 Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62072-456-56	2020-01-20	C162847	48780-1	9855e2a2-3c84-60a7-e053-dbdaa90a05bd	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: 2007
62072-456-56	2019-11-27	C162847	48780-1	9855e2a2-3c84-60a7-e053-dbdaa90a05bd	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: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62072-456-56	AmmoniaN 13	8 mL in 1 VIAL, GLASS	INJECTION	8		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
AMMONIA N-13	ACTIVE INGREDIENT	9OQO0E343Z	1
AMMONIA N-13	ACTIVE MOIETY	9OQO0E343Z	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ammonia N 13
AMMONIA N-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62072-456	62072-456-56

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMMONIA N-13	9OQO0E343Z	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A203938-001	AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP		2013-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203938-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203938-001	AMMONIA N 13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE / INTRAVENOUS	AP	2013-12-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203938-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203938-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203938-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203938-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203938-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203938-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203938-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203938-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203938-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203938-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203938-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203938-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203938-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203938-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203938-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203938-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203938-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203938-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203938-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203938-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203938-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203938-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203938-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203938-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203938-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203938-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203938-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203938-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203938-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203938-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203938-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203938-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203938-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203938-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203938-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203938-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203938-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203938-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203938-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203938-001	AP	1	`f41ea6bd6efb…`

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	Kreitchman PET Center	26572b37-0999-4c83-8206-1c088026d407	2026-01-27	Adverse reactions	Exact identifier ndc (package): 62072-456-56 ndc (product): 62072-456 ndc11 (package): 62072045656 spl id: bf01478c-3377-4b2c-905c-30807e865825 spl set id: 26572b37-0999-4c83-8206-1c088026d407

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.