Home NDC 75907-130-23 PHENYLEPHRINE HYDROCHLORIDE
Product NDC 75907-130
Requested package NDC 75907-130-23
11-digit product format 759070130
Labeler code 75907
Product ID 75907-130_1ac5cf56-b9c6-af78-0d96-22c38a182575
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENYLEPHRINE HYDROCHLORIDE
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Dr.Reddy's Laboratories Inc.,
Application ANDA218129
Marketing category ANDA
Marketing start 2025-01-14
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218129-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 A218129-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-02-19 14:30 UTC 2026-02 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218129-001 PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218129-002 PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS / OPHTHALMIC AT 2024-12-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 100 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 1234571 Internal RxNorm lookup 1234579 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 75907-130-23 PHENYLEPHRINE HYDROCHLORIDE 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 2 75907-130-23 PHENYLEPHRINE HYDROCHLORIDE 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-130 PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [DR.REDDY'S LABORATORIES INC.,] 1 Current NDC, 2 package rows 20250125_869917f1-ae26-40cd-d332-5a31a796b877.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 Sample Exclude flag Status 75907-130-23 75907013023 1 BOTTLE, DROPPER in 1 CARTON (75907-130-23) / 5 mL in 1 BOTTLE, DROPPER 2025-01-14 No No Current