Home NDC 42571-497 Proparacaine hydrochloride
Product NDC 42571-497
11-digit product format 425710497
Labeler code 42571
Product ID 42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Proparacaine hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA219294
Marketing category ANDA
Marketing start 2026-02-01
Substance PROPARACAINE HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Local Anesthesia [PE], Local Anesthetic [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 42 .
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 A219294-001 PROPARACAINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2025-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219294-001 AT
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 2026-08-18 06:07:40 2026-07 A219294-001 PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2025-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219294-001 PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2025-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219294-001 PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2025-10-20 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219294-001 PROPARACAINE HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2025-10-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219294-001 AT 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219294-001 AT 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219294-001 AT 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219294-001 AT 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Proparacaine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPARACAINE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U96OL57GOY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191013 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 42571-497-57 Proparacaine hydrochloride 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 1 42571-497-57 Proparacaine hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 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 Units Marketing start Sample Exclude flag Status 42571-497-57 42571049757 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE 1 bottle 2026-02-01 No No Current