Phenylephrine Hydrochloride

Product NDC: 0641-6229
11-digit product format: 006416229
Labeler code: 0641
Product ID: 0641-6229_031d1d06-e0be-4836-8180-92beded4510c
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: 2012-12-18
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1666372	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
c3f358dd-4a36-4808-9943-e01f88604be5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6229-01	Phenylephrine Hydrochloride	1 mL in 1 VIAL	INJECTION	1		4
0641-6229-25	Phenylephrine Hydrochloride	25 in 1 CARTON	INJECTION	25		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6229-01	ML - Milliliter	0641-6229	a50dcb02-6128-4a55-b72d-022f85304e6c	1	2018-11-06
0641-6229-25	ML - Milliliter	0641-6229	c28bb666-7add-4bc3-adc8-a71731b74868	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6229	PHENYLEPHRINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240412_c3f358dd-4a36-4808-9943-e01f88604be5.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 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
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
1666372	phenylephrine HCl 10 MG in 1 ML Injection	PSN	c3f358dd-4a36-4808-9943-e01f88604be5	4
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	c3f358dd-4a36-4808-9943-e01f88604be5	4
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	c3f358dd-4a36-4808-9943-e01f88604be5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6229-01	00641622901	1 mL in 1 VIAL	1 ml					Historical
0641-6229-25	00641622925	25 VIAL in 1 CARTON (0641-6229-25) / 1 mL in 1 VIAL (0641-6229-01)	25 vial	2012-12-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenylephrine Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	4