PHENYLEPHRINE HYDROCHLORIDE

Product NDC: 65145-116
11-digit product format: 651450116
Labeler code: 65145
Product ID: 65145-116_93087431-1c8f-4b1d-9ce3-0b42aa219a3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Caplin Steriles Limited
Application: ANDA213318
Marketing category: ANDA
Marketing start: 2026-04-28
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 50 mg/5mL
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
A213318-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11
A213318-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11
A213318-003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213318-001	AP1
A213318-002	AP1
A213318-003	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	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213318-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-06-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A213318-001	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213318-002	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213318-003	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-001	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-002	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213318-003	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213318-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213318-002	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213318-003	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-002	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213318-003	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-002	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213318-003	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-002	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213318-003	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-002	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213318-003	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-001	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-002	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213318-003	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-001	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-002	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213318-003	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213318-001	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213318-002	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213318-003	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-001	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-002	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213318-003	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-001	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-002	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213318-003	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-001	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-002	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213318-003	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213318-001	AP1	1	`8072bd15b7f6…`

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	50 mg/5mL

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
1b9f1d54-ea46-49c8-a33e-c94a61bc0460	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65145-116-01	PHENYLEPHRINE HYDROCHLORIDE	1 in 1 CARTON	INJECTION	1	6
65145-116-01	PHENYLEPHRINE HYDROCHLORIDE	5 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION	5	6
65145-116-10	PHENYLEPHRINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION	10	6
65145-116-10	PHENYLEPHRINE HYDROCHLORIDE	5 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION	5	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65145-116-01	ML - Milliliter	65145-116	716ef7b0-ca04-4aeb-a619-9e24eb41c49b	1	2026-02-05
65145-116-10	ML - Milliliter	65145-116	3640af1e-1ec5-4b8c-9fd8-ef59475ec3b4	1	2026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65145-116	PHENYLEPHRINE HYDROCHLORIDE INJECTION [CAPLIN STERILES LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20200630_1b9f1d54-ea46-49c8-a33e-c94a61bc0460.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Caplin Steriles Limited	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318 ndc (product): 65145-116
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	41eec9e9-6e94-15d4-e063-6394a90a98a2	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Somerset Therapeutics, LLC	18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d89d7004-e20a-0a35-e053-2a95a90a7b78	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Armas Pharmaceuticals Inc.	16c02d53-fd3f-4fd7-abbe-f1358ea0891f	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	abd39d9c-fcda-4d01-8a58-1d54ba7ac651	2021-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Somerset Therapeutics, LLC	90a3853e-49d6-4536-be72-82cc875bcf74	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213318 application number: ANDA213318

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	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1232651	phenylephrine HCl 10 MG/ML Injectable Solution	PSN	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1232651	phenylephrine hydrochloride 10 MG/ML Injectable Solution	SCD	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1232651	phenylephrine hydrochloride 1 % Injectable Solution	SY	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1232651	phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution	SY	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6
1232651	phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution	SY	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65145-116-01	65145011601	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65145-116-01) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE	2026-04-28	0000-00-00	No	No	Current
65145-116-10	65145011610	10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65145-116-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE	2026-04-28		No	No	Current