Application 203826

Type: NDA
Sponsor: WEST WARD PHARM CORP

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)	Yes	Yes
002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML)	Yes	Yes
003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	100MG/10ML (10MG/ML)	Yes	Yes
004	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	0.5MG/5ML (0.1MG/ML)	Yes	Yes
005	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	1MG/10ML (0.1MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203826-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20
N203826-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19
N203826-003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19
N203826-004	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09
N203826-005	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203826-001	AP2
N203826-002	AP2
N203826-003	AP2

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N203826-004	11471400	2036-08-05	Drug product	2023-03-22
N203826-004	11213480	2036-09-26	Drug product	2023-03-22
N203826-004	12257342	2036-09-26	Drug product	2025-04-23
N203826-005	11471400	2036-08-05	Drug product	2023-03-22
N203826-005	11213480	2036-09-26	Drug product	2023-03-22
N203826-005	12257342	2036-09-26	Drug product	2025-04-23

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 5 · 167 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
2026-02-19 14:30 UTC	2026-02	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 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	N203826-001	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-002	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-003	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-001	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-002	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-003	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-001	AP2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-001	AP2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-001	AP2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-001	AP2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-001	AP2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-001	AP2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-001	AP2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203826-001	AP2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203826-001	AP2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203826-001	AP2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203826-001	AP2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203826-001	AP2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-001	AP2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-002	AP2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-003	AP2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203826-001	AP2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203826-002	AP2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203826-003	AP2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203826-001	AP2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203826-002	AP2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203826-003	AP2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203826-001	AP2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203826-002	AP2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203826-003	AP2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203826-001	AP2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203826-002	AP2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203826-003	AP2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203826-001	AP2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203826-002	AP2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203826-003	AP2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-001	AP2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-002	AP2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-003	AP2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203826-001	AP2	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`d8e5a09893c0…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Civica, Inc.	7a23ed28-3912-4398-b660-bf9ec3ee3926	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826 ndc (product): 72572-570 ndc (product): 72572-571
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c3f358dd-4a36-4808-9943-e01f88604be5	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826 ndc (product): 0641-6229
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826 ndc (product): 0641-6142 ndc (product): 0641-6189 ndc (product): 0641-6188
PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	7602fb73-3ce3-5978-e053-2991aa0abea3	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826 ndc (product): 51662-1249
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d88a01c4-9681-2695-e053-2995a90a62ea	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826 ndc (product): 71872-7043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6142	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6142	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6142	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6188	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6188	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6189	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6189	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6229	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6229	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	West-Ward Pharmaceuticals Corp.	NDA	Current
51662-1249	PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1249	PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1249	PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1249	PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1249	PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-142	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-142	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
55154-5129	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Cardinal Health	NDA	Current
55154-5129	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Cardinal Health	NDA	Current
70518-1038	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
71872-7043	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current
72572-570	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Civica, Inc.	NDA	Current
72572-571	Phenylephrine Hydrochloride	Phenylephrine Hydrochloride	Civica, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73800	SUPPL	2023-03-17
73799	SUPPL	2023-03-17
73723	SUPPL	2023-03-10
73722	SUPPL	2023-03-10
64847	SUPPL	2020-10-06
45268	SUPPL	2016-09-12
45240	SUPPL	2016-09-06
44889	ORIG	2013-05-24
43445	ORIG	2013-05-24
10252	ORIG	2012-12-26
19494	ORIG	2012-12-21