Home NDC 67296-2176 PREDNISOLONE ACETATE
Product NDC 67296-2176
11-digit product format 672962176
Labeler code 67296
Product ID 67296-2176_44f6dd75-df38-6985-e063-6294a90a80cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prednisolone acetate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Redpharm Drug
Application ANDA216935
Marketing category ANDA
Marketing start 2024-10-11
Substance PREDNISOLONE ACETATE
Active strength 10 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216935-001 PREDNISOLONE ACETATE PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216935-001 AB
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 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216935-001 PREDNISOLONE ACETATE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2024-08-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216935-001 CGT 2025-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216935-001 CGT 2025-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216935-001 CGT 2025-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216935-001 CGT 2025-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216935-001 CGT 2025-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216935-001 CGT 2025-04-09 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216935-001 CGT 2025-04-09 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base PREDNISOLONE ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE ACETATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8B2807733D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1376336 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 67296-2176-5 PREDNISOLONE ACETATE 1 in 1 CARTON SUSPENSION/ DROPS 1 2 67296-2176-5 PREDNISOLONE ACETATE 5 mL in 1 BOTTLE SUSPENSION/ DROPS 5 2
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 · 3 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 67296-2176-5 67296217605 1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE 1 bottle 2024-10-11 No No Current