Home NDC 0404-9931 Phenylephrine Hydrochloride
Product NDC 0404-9931
11-digit product format 004049931
Labeler code 0404
Product ID 0404-9931_a4ecb606-abf4-4f16-9c91-13d33831033c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA211079
Marketing category ANDA
Marketing start 2022-01-13
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 A211079-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211079-001 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 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 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211079-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-07-05 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9931-99 Phenylephrine Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 5 0404-9931-99 Phenylephrine Hydrochloride 1 in 1 BAG INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9931 PHENYLEPHRINE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240327_db313f72-a6bb-444f-949f-19b4aa6f61c0.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9931-99 00404993199 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99) / 1 mL in 1 VIAL, SINGLE-DOSE 2022-01-13 0000-00-00 No No Current