Home NDC 76420-438 Tropicamide
Product NDC 76420-438
11-digit product format 764200438
Labeler code 76420
Product ID 76420-438_3c135180-271c-9a2b-e063-6294a90a0164
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tropicamide
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler ASCLEMED USA INC.
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 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 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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76420-438-15 Tropicamide 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 1 76420-438-15 Tropicamide 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76420-438-15 76420043815 1 BOTTLE in 1 CARTON (76420-438-15) / 15 mL in 1 BOTTLE 1 bottle 2025-08-07 No No Historical