Home NDC 51662-1576 PHENYLEPHRINE HYDROCHLORIDE
Product NDC 51662-1576
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 1 .
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 · 41 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 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…2022-09-29 23:25 UTC 2022-09 A210665-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2019-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210665-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2019-01-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 (product): 51662-1576 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
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 51662-1576-1 51662157601 1 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1) 1 ml 2021-06-30 0000-00-00 No No Current 51662-1576-2 51662157602 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 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