AMINOPHYLLINE

Product NDC: 51662-1341
11-digit product format: 516621341
Labeler code: 51662
Product ID: 51662-1341_1057db94-30a8-224a-e063-6394a90a020d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMINOPHYLLINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA087242
Marketing category: ANDA
Marketing start: 2019-02-10
Substance: AMINOPHYLLINE DIHYDRATE
Active strength: 25 mg/mL
Pharmacologic classes: Methylxanthine [EPC], Xanthines [CS]
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
A087242-001	AMINOPHYLLINE	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-10-26

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RLD, RS	1983-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087242-001	AMINOPHYLLINE	25MG/ML	INJECTABLE / INJECTION	RS	1983-10-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: AMINOPHYLLINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMINOPHYLLINE DIHYDRATE	25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C229N9DX94	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1724666	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
819207a2-0c37-b275-e053-2a91aa0afb36	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1d07c79-5983-427d-b6f5-df0550dcc598	Product name	4	20250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2	Product name	1	20170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1341-1	AMINOPHYLLINE	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	7
51662-1341-2	AMINOPHYLLINE	1 mL in 1 POUCH	INJECTION, SOLUTION	1	7
51662-1341-3	AMINOPHYLLINE	25 in 1 CASE	INJECTION, SOLUTION	25	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1341	AMINOPHYLLINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	7	Current NDC, Legacy NDC, 3 package rows	20240202_819207a2-0c37-b275-e053-2a91aa0afb36.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMINOPHYLLINE	AMINOPHYLLINE	HF Acquisition Co LLC, DBA HealthFirst	819207a2-0c37-b275-e053-2a91aa0afb36	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242 ndc (product): 51662-1341
Aminophylline	AMINOPHYLLINE	Medical Purchasing Solutions, LLC	52bbc6cd-4baf-7859-e063-6394a90ac87d	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
Aminophylline	AMINOPHYLLINE	Hospira, Inc.	9a663ef3-881f-48bd-2689-3713b24545c2	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
Aminophylline	AMINOPHYLLINE	ProPharma Distribution	3f000254-a9f1-c8c7-e063-6394a90aa33f	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
Aminophylline	AMINOPHYLLINE	Henry Schein, Inc.	9066bdd0-cb03-40ed-abfa-1b6fb1fff607	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
Aminophylline	AMINOPHYLLINE	Henry Schein, Inc.	9a9dedc4-ce04-4b22-9922-81a215ff59ed	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
AMINOPHYLLINE	AMINOPHYLLINE	HF Acquisition Co LLC, DBA HealthFirst	75c2fc3e-28ac-c1b1-e053-2991aa0aee9f	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242
Aminophylline	AMINOPHYLLINE	Medical Purchasing Solutions, LLC	6bca324f-6999-4c16-e053-2a91aa0aee45	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087242 application number: ANDA087242

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C229N9DX94	AMINOPHYLLINE DIHYDRATE	5897-66-5	AMINOPHYLLINE DIHYDRATE
27Y3KJK423	AMINOPHYLLINE	317-34-0	AMINOPHYLLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1724666	aminophylline 500 MG in 20 ML Injection	PSN	819207a2-0c37-b275-e053-2a91aa0afb36	7
1724666	20 ML aminophylline 25 MG/ML Injection	SCD	819207a2-0c37-b275-e053-2a91aa0afb36	7
1724666	aminophylline (as aminophylline dihydrate) 500 MG per 20 ML Injection	SY	819207a2-0c37-b275-e053-2a91aa0afb36	7
1724666	aminophylline 500 MG per 20 ML Injection	SY	819207a2-0c37-b275-e053-2a91aa0afb36	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1341-1	51662134101	20 mL in 1 VIAL, SINGLE-DOSE (51662-1341-1)	20 ml	2019-02-10	0000-00-00	No	No	Current
51662-1341-2	51662134102	1 mL in 1 POUCH	1 ml					Historical
51662-1341-3	51662134103	25 POUCH in 1 CASE (51662-1341-3) / 1 mL in 1 POUCH (51662-1341-2)	25 pouch	2020-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMINOPHYLLINE INJ., USP 500mg (25mg/mL) 20mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	8