Phenylephrine Hydrochloride

Product NDC: 0641-6188
11-digit product format: 006416188
Labeler code: 0641
Product ID: 0641-6188_f73e455e-cbfa-48af-b4ce-505de8e8f761
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA203826
Marketing category: NDA
Marketing start: 2019-06-19
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenylephrine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1232651	Internal RxNorm lookup
1666372	Internal RxNorm lookup
2262018	Internal RxNorm lookup
2634228	Internal RxNorm lookup
2634233	Internal RxNorm lookup
2634235	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
e1a7ab4b-0afe-4463-a039-5be0323cf2f7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6188-01	Phenylephrine Hydrochloride	5 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION	5		12
0641-6188-10	Phenylephrine Hydrochloride	10 in 1 CARTON	INJECTION	10		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6188-01	ML - Milliliter	0641-6188	0d8aac8b-9871-4eee-aad5-d748056e15d5	1	2019-09-05
0641-6188-10	ML - Milliliter	0641-6188	dc2725e9-f36f-4048-8606-000855e71be6	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6188	PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.]	12	Current NDC, Legacy NDC, 2 package rows	20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.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 · 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
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
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): 0641-6188
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2634233	IMMPHENTIV 1000 MCG in 10 ML Injection	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634235	IMMPHENTIV 500 MCG in 5 ML Injection	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1666372	phenylephrine HCl 10 MG in 1 ML Injection	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1232651	phenylephrine HCl 10 MG/ML Injectable Solution	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634228	phenylephrine hydrochloride 1000 MCG in 10 ML Injection	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2262018	phenylephrine hydrochloride 500 MCG in 5 mL Injection	PSN	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634233	10 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv]	SBD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634235	5 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv]	SBD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634228	10 ML phenylephrine hydrochloride 0.1 MG/ML Injection	SCD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2262018	5 ML phenylephrine hydrochloride 0.1 MG/ML Injection	SCD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1232651	phenylephrine hydrochloride 10 MG/ML Injectable Solution	SCD	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634233	Immphentiv 0.1 MG/ML per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634235	Immphentiv 0.1 MG/ML per 5 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634235	Immphentiv 0.5 MG per 5 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634233	Immphentiv 1 MG per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634233	Immphentiv 1000 MCG per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634235	Immphentiv 500 MCG per 5 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634228	phenylephrine hydrochloride 0.1 MG/ML per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1232651	phenylephrine hydrochloride 1 % Injectable Solution	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634228	phenylephrine hydrochloride 1 MG per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1232651	phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2634228	phenylephrine hydrochloride 1000 MCG per 10 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
1232651	phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12
2262018	phenylephrine hydrochloride 500 MCG per 5 ML Injection	SY	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6188-01	00641618801	5 mL in 1 VIAL, PHARMACY BULK PACKAGE	5 ml					Historical
0641-6188-10	00641618810	10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0641-6188-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6188-01)		2019-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	12