Home NDC 85766-040 Tropicamide
Product NDC 85766-040
11-digit product format 857660040
Labeler code 85766
Product ID 85766-040_4a2ba794-da99-91aa-e063-6394a90a8370
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tropicamide
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sportpharm LLC
Application ANDA207524
Marketing category ANDA
Marketing start 2019-12-12
Substance TROPICAMIDE
Active strength 10 mg/mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 A207524-001 TROPICAMIDE TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207524-001 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 2026-02-19 14:30 UTC 2026-02 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207524-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 2019-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tropicamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROPICAMIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N0A3Z5XTC6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314238 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 85766-040-15 Tropicamide 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 2 85766-040-15 Tropicamide 1 in 1 CARTON SOLUTION/ DROPS 1 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 · 2 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 85766-040-15 85766004015 1 BOTTLE in 1 CARTON (85766-040-15) / 15 mL in 1 BOTTLE 1 bottle 2025-08-07 No No Current