Home NDC 70069-591 Phenylephrine Hydrochloride
Product NDC 70069-591
11-digit product format 700690591
Labeler code 70069
Product ID 70069-591_5bc23817-cddb-4448-bbf3-969db4cee912
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA215617
Marketing category ANDA
Marketing start 2025-03-04
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength .1 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 43 .
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 A215617-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215617-001 AP
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 2026-09-14 22:38:34 2026-08 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215617-001 PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2025-02-14 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 .1 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 2262018 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 70069-591-01 Phenylephrine Hydrochloride 5 mL in 1 AMPULE SOLUTION 5 7 70069-591-10 Phenylephrine Hydrochloride 10 in 1 CARTON SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-591 PHENYLEPHRINE HYDROCHLORIDE SOLUTION [SOMERSET THERAPEUTICS, LLC] 7 Current NDC, 2 package rows 20250306_170e63f1-23f4-4839-ab89-b81832d94a56.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 · 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 70069-591-01 70069059101 5 mL in 1 AMPULE 5 ml Historical 70069-591-10 70069059110 10 AMPULE in 1 CARTON (70069-591-10) / 5 mL in 1 AMPULE (70069-591-01) 10 ampule 2025-03-04 No No Current