Home NDC 36000-362-05 phenylephrine hydrochloride
Product NDC 36000-362
Requested package NDC 36000-362-05
11-digit product format 360000362
Labeler code 36000
Product ID 36000-362_74192a42-0ff7-443b-9d8a-3096ef5c8e43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenylephrine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA217032
Marketing category ANDA
Marketing start 2026-04-06
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 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 RLD / RS Approval date A217032-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03 A217032-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03 A217032-003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2026-04-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-001 AP1 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-002 AP1 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217032-003 AP1 1 a50c72e98297…
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 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 36000-362-05 phenylephrine hydrochloride 5 in 1 CARTON INJECTION 5 1 36000-362-05 phenylephrine hydrochloride 10 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 10 1
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 36000-362-05 36000036205 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (36000-362-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2026-04-06 No No Current