Application 211079

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/ML (10MG/ML)	No	No

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
A211079-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2018-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211079-001	AP1

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211079-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211079-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211079-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211079-001	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211079-001	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211079-001	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211079-001	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211079-001	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211079-001	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211079-001	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211079-001	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211079-001	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211079-001	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211079-001	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211079-001	AP1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211079-001	AP1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211079-001	AP1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211079-001	AP1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211079-001	AP1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211079-001	AP1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211079-001	AP1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211079-001	AP1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211079-001	AP1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211079-001	AP1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211079-001	AP1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211079-001	AP1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211079-001	AP1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211079-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211079-001	AP1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211079-001	AP1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211079-001	AP1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211079-001	AP1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211079-001	AP1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211079-001	AP1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211079-001	AP1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211079-001	AP1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211079-001	AP1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211079-001	AP1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211079-001	AP1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211079-001	AP1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211079-001	AP1	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 107, LLC	6d59ee85-08e5-452d-a09a-35fcc2a82b75	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211079 application number: ANDA211079 ndc (product): 55154-8226
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Henry Schein, Inc.	db313f72-a6bb-444f-949f-19b4aa6f61c0	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211079 application number: ANDA211079 ndc (product): 0404-9931
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	fad93be4-32dd-44c1-a20f-2b0bb3b41929	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211079 application number: ANDA211079 ndc (product): 70121-1577
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86abb371-3ac9-9f74-e053-2991aa0a66af	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211079 application number: ANDA211079 ndc (product): 71872-7159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9931	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9931	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Henry Schein, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-577	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
55154-8226	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Cardinal Health	ANDA	Current
55154-8226	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Cardinal Health	ANDA	Current
55154-8226	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Cardinal Health 107, LLC	ANDA	Current
70121-1577	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Biosciences LLC	ANDA	Current
70121-1577	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1577	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1577	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
71872-7159	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current