Home NDC 43598-182 phenylephrine hydrochloride injection, solution
Product NDC 43598-182
11-digit product format 435980182
Labeler code 43598
Product ID 43598-182_933d3739-a253-94c4-c37e-7872f700ba79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenylephrine hydrochloride injection, solution
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Dr. Reddy's Laboratories Inc.
Application NDA216830
Marketing category NDA
Marketing start 2025-07-01
Substance PHENYLEPHRINE
Active strength 80 ug/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216830-001 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE PHENYLEPHRINE HYDROCHLORIDE 20MG/250ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-30
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216830-001 12564561 2044-08-08 Drug product 2026-03-27
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 2026-02-19 14:30 UTC 2026-02 N216830-001 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/250ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216830-001 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/250ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216830-001 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/250ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216830-001 PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/250ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-30 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216830-001 12564561 2044-08-08 Drug product 2026-03-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base phenylephrine hydrochloride injection, solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE 80 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1WS297W6MV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717659 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 43598-182-05 phenylephrine hydrochloride injection, solution 5 in 1 CARTON INJECTION, SOLUTION 5 3 43598-182-50 phenylephrine hydrochloride injection, solution 250 mL in 1 BAG INJECTION, SOLUTION 250 3
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 Units Marketing start Sample Exclude flag Status 43598-182-05 43598018205 5 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50) 5 bag 2025-07-01 No No Current 43598-182-50 43598018250 250 mL in 1 BAG 250 ml Historical