Home NDC 24208-590 Tropicamide
Product NDC 24208-590
11-digit product format 242080590
Labeler code 24208
Product ID 24208-590_f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tropicamide
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application ANDA040067
Marketing category ANDA
Marketing start 1994-07-27
Substance TROPICAMIDE
Active strength 5 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 A040067-001 TROPICAMIDE TROPICAMIDE 0.5% 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 A040067-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040067-001 TROPICAMIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 1994-07-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tropicamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROPICAMIDE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313521 Internal RxNorm lookup 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 24208-590-64 Tropicamide 1 in 1 CARTON SOLUTION/ DROPS 1 9 24208-590-64 Tropicamide 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-590 TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 9 Current NDC, Legacy NDC, 2 package rows 20231027_892b78c8-36bc-47d3-850e-502899b48fb9.zip
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 Marketing start Marketing end Sample Exclude flag Status 24208-590-64 24208059064 1 BOTTLE, DROPPER in 1 CARTON (24208-590-64) / 15 mL in 1 BOTTLE, DROPPER 1994-07-27 0000-00-00 No No Current