Phenylephrine hydrochloride

Product NDC: 42023-214
Requested package NDC: 42023-214-10
11-digit product format: 420230214
Labeler code: 42023
Product ID: 42023-214_e3034d8d-c47d-4ef2-aa1b-97953b1f3036
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Par Health USA, LLC
Application: ANDA210025
Marketing category: ANDA
Marketing start: 2019-07-17
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: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210025-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21
A210025-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21
A210025-003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210025-002	AP1
A210025-003	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 4 · 123 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	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210025-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210025-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210025-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		2018-12-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 91 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	A210025-002	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210025-003	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210025-002	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210025-003	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210025-002	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210025-003	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210025-002	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210025-003	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210025-002	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210025-003	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210025-002	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210025-003	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210025-002	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210025-003	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210025-002	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210025-003	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210025-002	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210025-003	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210025-002	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210025-003	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210025-002	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210025-003	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210025-002	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210025-003	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210025-002	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210025-003	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210025-002	AP1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210025-003	AP1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210025-002	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210025-003	AP1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210025-002	AP1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210025-003	AP1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210025-002	AP1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210025-003	AP1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210025-001	AP1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210025-002	AP1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210025-003	AP1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210025-002	AP1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210025-003	AP1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210025-001	AP1	1	`782e0a99824c…`

Additional Listing Data#

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

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
1232651	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
d92631a6-bae8-493b-b4df-c563346607a8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-214-10	Phenylephrine hydrochloride	10 in 1 CARTON	INJECTION	10		15
42023-214-10	Phenylephrine hydrochloride	5 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION	5		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-214-10	ML - Milliliter	42023-214	b6587dd1-ccc6-49df-9ea7-397ebd479b91	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-214	PHENYLEPHRINE HYDROCHLORIDE INJECTION [ENDO USA, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240913_d92631a6-bae8-493b-b4df-c563346607a8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Par Health USA, LLC	d92631a6-bae8-493b-b4df-c563346607a8	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210025 application number: ANDA210025 ndc (package): 42023-214-10 ndc (product): 42023-214 ndc11 (package): 42023021410

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
1232651	phenylephrine HCl 10 MG/ML Injectable Solution	PSN	d92631a6-bae8-493b-b4df-c563346607a8	15
1232651	phenylephrine hydrochloride 10 MG/ML Injectable Solution	SCD	d92631a6-bae8-493b-b4df-c563346607a8	15
1232651	phenylephrine hydrochloride 1 % Injectable Solution	SY	d92631a6-bae8-493b-b4df-c563346607a8	15
1232651	phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution	SY	d92631a6-bae8-493b-b4df-c563346607a8	15
1232651	phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution	SY	d92631a6-bae8-493b-b4df-c563346607a8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-214-10	42023021410	10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (42023-214-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE	2019-07-17	0000-00-00	No	No	Current