Home NDC 0781-3422-70 Phenylephrine Hydrochloride
Product NDC 0781-3422
Requested package NDC 0781-3422-70
11-digit product format 007813422
Labeler code 0781
Product ID 0781-3422_14eec16d-4652-44a3-8cd3-a37b4280deb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA208905
Marketing category ANDA
Marketing start 2019-09-05
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 RLD / RS Approval date A208905-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 A208905-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 A208905-003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RS 2019-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208905-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208905-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208905-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2019-01-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 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 0781-3422-70 Phenylephrine Hydrochloride 1 in 1 CARTON INJECTION 1 20 0781-3422-70 Phenylephrine Hydrochloride 10 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 10 20 0781-3422-71 Phenylephrine Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 20 0781-3422-75 Phenylephrine Hydrochloride 5 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 5 20 0781-3422-92 Phenylephrine Hydrochloride 10 in 1 CARTON INJECTION 10 20 0781-3422-95 Phenylephrine Hydrochloride 10 in 1 CARTON INJECTION 10 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3422 PHENYLEPHRINE HYDROCHLORIDE INJECTION [SANDOZ INC] 19 Current NDC, Legacy NDC, 6 package rows 20221018_6feb2da2-05ef-47bb-9d8d-01b81ad69059.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 · 2 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 0781-3422-70 00781342270 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3422-70) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2019-09-05 2021-04-30 No No Current