Home NDC 85766-278 Tropicamide
Product NDC 85766-278
11-digit product format 857660278
Labeler code 85766
Product ID 85766-278_5b1b3864-09bd-f2a0-e063-6394a90a110b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tropicamide
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sportpharm LLC
Application ANDA040064
Marketing category ANDA
Marketing start 1994-07-27
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 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 A040064-001 TROPICAMIDE TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040064-001 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.
Product history page 1 of 2 · 43 observed 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 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040064-001 TROPICAMIDE 1% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Tropicamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROPICAMIDE 10 mg/mL
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85766-278-15 85766027815 1 BOTTLE, DROPPER in 1 CARTON (85766-278-15) / 15 mL in 1 BOTTLE, DROPPER 2026-09-10 No No Current