Home NDC 72572-570 Phenylephrine Hydrochloride
Product NDC 72572-570
11-digit product format 725720570
Labeler code 72572
Product ID 72572-570_56c751ad-8730-4f55-9169-8cf19e52f54b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Civica, Inc.
Application NDA203826
Marketing category NDA
Marketing start 2020-12-02
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.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code 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.
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 Use code 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 · 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72572-570-01 Phenylephrine Hydrochloride 10 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 10 3 72572-570-10 Phenylephrine Hydrochloride 10 in 1 CARTON INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72572-570 PHENYLEPHRINE HYDROCHLORIDE INJECTION [CIVICA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241228_7a23ed28-3912-4398-b660-bf9ec3ee3926.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 ndc (product): 72572-570 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72572-570-01 72572057001 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 10 ml Historical 72572-570-10 72572057010 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72572-570-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (72572-570-01) 2020-12-02 0000-00-00 No No Current