PHENYLEPHRINE HYDROCHLORIDE

Product NDC: 51662-1576
Requested package NDC: 51662-1576-3
11-digit product format: 516621576
Labeler code: 51662
Product ID: 51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA210665
Marketing category: ANDA
Marketing start: 2021-06-30
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210665-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2		2019-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210665-001	AP2

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210665-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	2019-01-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210665-001	AP2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210665-001	AP2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210665-001	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210665-001	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210665-001	AP2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210665-001	AP2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210665-001	AP2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210665-001	AP2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210665-001	AP2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210665-001	AP2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210665-001	AP2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210665-001	AP2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210665-001	AP2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210665-001	AP2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210665-001	AP2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210665-001	AP2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210665-001	AP2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210665-001	AP2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210665-001	AP2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210665-001	AP2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210665-001	AP2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210665-001	AP2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210665-001	AP2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210665-001	AP2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210665-001	AP2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210665-001	AP2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210665-001	AP2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210665-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210665-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210665-001	AP2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210665-001	AP2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210665-001	AP2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210665-001	AP2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210665-001	AP2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210665-001	AP2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210665-001	AP2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210665-001	AP2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210665-001	AP2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210665-001	AP2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210665-001	AP2	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c600fe14-40b6-2b5a-e053-2a95a90aff98	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	SPL version
51662-1576-1	PHENYLEPHRINE HYDROCHLORIDE	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	4
51662-1576-2	PHENYLEPHRINE HYDROCHLORIDE	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	4
51662-1576-2	PHENYLEPHRINE HYDROCHLORIDE	1 in 1 POUCH	INJECTION	1	4
51662-1576-3	PHENYLEPHRINE HYDROCHLORIDE	25 in 1 CASE	INJECTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1576	PHENYLEPHRINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 4 package rows	20240224_c600fe14-40b6-2b5a-e053-2a95a90aff98.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	b54a0c59-e5e4-4fd7-ba91-c991ce87b148	2025-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210665 application number: ANDA210665
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210665 application number: ANDA210665
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c600fe14-40b6-2b5a-e053-2a95a90aff98	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210665 application number: ANDA210665 ndc (package): 51662-1576-3 ndc (product): 51662-1576 ndc11 (package): 51662157603
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f2dce7f1-6538-4747-9792-665eee45c0a9	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210665 application number: ANDA210665

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	c600fe14-40b6-2b5a-e053-2a95a90aff98	4
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	c600fe14-40b6-2b5a-e053-2a95a90aff98	4
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	c600fe14-40b6-2b5a-e053-2a95a90aff98	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1576-3	51662157603	25 POUCH in 1 CASE (51662-1576-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2) / 1 mL in 1 VIAL, SINGLE-DOSE	25 pouch	2022-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 10mg PER mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	4