Phenylephrine hydrochloride

Product NDC: 81284-212
Requested package NDC: 81284-212-10
11-digit product format: 812840212
Labeler code: 81284
Product ID: 81284-212_9302b62e-3f80-4e5c-afa5-a775ed2c2ebe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Provepharm Inc.
Application: ANDA211081
Marketing category: ANDA
Marketing start: 2020-08-12
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211081-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17
A211081-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17
A211081-003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211081-001	AP1
A211081-002	AP1
A211081-003	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 3 · 111 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	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211081-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-07-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A211081-001	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211081-002	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211081-003	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-001	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-002	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211081-003	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211081-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211081-002	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211081-003	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-002	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211081-003	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-002	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211081-003	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-002	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211081-003	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-002	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211081-003	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-001	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-002	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211081-003	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-001	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-002	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211081-003	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211081-001	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211081-002	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211081-003	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-001	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-002	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211081-003	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-001	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-002	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211081-003	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-001	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-002	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211081-003	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211081-001	AP1	1	`8072bd15b7f6…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1232651	Internal RxNorm lookup
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
e1d3881f-fa9e-4d68-8ef0-9e03435fc292	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81284-212-00	Phenylephrine hydrochloride	5 mL in 1 VIAL	INJECTION	5		6
81284-212-10	Phenylephrine hydrochloride	10 in 1 CARTON	INJECTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81284-212-00	ML - Milliliter	81284-212	1faf0885-7fb0-49a7-9caa-04a07551861c	1	2023-03-13
81284-212-10	ML - Milliliter	81284-212	e93c1cf7-80be-46cf-8b01-02925717a43f	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81284-212	PHENYLEPHRINE HYDROCHLORIDE INJECTION [PROVEPHARM INC.]	5	Current NDC, Legacy NDC, 2 package rows	20241103_e1d3881f-fa9e-4d68-8ef0-9e03435fc292.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Provepharm Inc.	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211081 application number: ANDA211081 ndc (package): 81284-212-10 ndc (product): 81284-212 ndc11 (package): 81284021210
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Medical Purhasing Solutions, LLC	0930ec92-5654-078f-e063-6294a90aad02	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211081 application number: ANDA211081

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	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1232651	phenylephrine HCl 10 MG/ML Injectable Solution	PSN	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1232651	phenylephrine hydrochloride 10 MG/ML Injectable Solution	SCD	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1232651	phenylephrine hydrochloride 1 % Injectable Solution	SY	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1232651	phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution	SY	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6
1232651	phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution	SY	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81284-212-10	81284021210	10 VIAL in 1 CARTON (81284-212-10) / 5 mL in 1 VIAL (81284-212-00)	10 vial	2020-08-12	0000-00-00	No	No	Current