Home NDC 17478-097 Cyclopentolate Hydrochloride
Product NDC 17478-097
11-digit product format 174780097
Labeler code 17478
Product ID 17478-097_ea22dcc7-ab6d-432b-a668-ac87777d0845
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclopentolate Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Akorn
Application ANDA040165
Marketing category ANDA
Marketing start 1997-01-13
Marketing end 0000-00-00
Substance CYCLOPENTOLATE HYDROCHLORIDE
Active strength 20 mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040165-001 AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040165-001 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 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040165-001 AKPENTOLATE 2% SOLUTION/DROPS / OPHTHALMIC AT 1997-01-13 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cyclopentolate Hydrochloride ACTIVE INGREDIENT 736I6971TE CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 Cyclopentolate ACTIVE MOIETY I76F4SHP7J CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 boric acid INACTIVE INGREDIENT R57ZHV85D4 CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 potassium chloride INACTIVE INGREDIENT 660YQ98I10 CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 sodium carbonate INACTIVE INGREDIENT 45P3261C7T CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [AKORN, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17478-097-02 17478009702 1 BOTTLE, DROPPER in 1 CARTON (17478-097-02) > 2 mL in 1 BOTTLE, DROPPER 1997-01-13 0000-00-00 No No Current 17478-097-10 17478009710 1 BOTTLE, DROPPER in 1 CARTON (17478-097-10) > 5 mL in 1 BOTTLE, DROPPER 1997-01-13 0000-00-00 No No Current 17478-097-12 17478009712 1 BOTTLE, DROPPER in 1 CARTON (17478-097-12) > 15 mL in 1 BOTTLE, DROPPER 1997-01-13 0000-00-00 No No Current