Cyclopentolate Hydrochloride

Product NDC
50090-3874
11-digit product format
500903874
Labeler code
50090
Product ID
50090-3874_3b7f075e-0274-493e-8532-3b1faebc61e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclopentolate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA040164
Marketing category
ANDA
Marketing start
1997-01-13
Marketing end
0000-00-00
Substance
CYCLOPENTOLATE HYDROCHLORIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3874IInactivated by FDA2026-08-07
excluded packagepackage50090-387450090-3874-1IInactivated by FDA2026-08-07

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3874-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3874-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3874-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3874-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3874-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3874-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3874-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3874-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3874-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3874-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3874-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3874-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3874-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3874-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3874-11332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040164-001AKPENTOLATECYCLOPENTOLATE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040164-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040164-001AKPENTOLATE1%SOLUTION/DROPS / OPHTHALMICAT1997-01-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040164-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040164-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040164-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040164-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040164-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040164-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040164-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040164-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040164-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040164-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040164-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040164-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040164-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040164-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040164-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040164-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040164-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040164-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040164-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040164-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040164-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040164-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040164-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040164-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040164-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040164-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040164-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040164-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040164-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040164-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040164-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040164-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040164-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040164-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040164-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040164-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040164-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040164-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040164-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040164-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
da26936b-2875-4173-812f-99a1f7074052Product name120151215
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3874-12023-01-30C16284748780-1f386c649-a14b-0266-e053-dadaa90a7c1aCyclopentolate Hydrochloride Ophthalmic Solution, USP -Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3874-1Cyclopentolate Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
50090-3874-1Cyclopentolate Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3874CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20200121_c53c8090-921f-45c5-bcd1-ce156ae3bb28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298066cyclopentolate HCl 1 % Ophthalmic SolutionPSNc53c8090-921f-45c5-bcd1-ce156ae3bb284
1298066cyclopentolate hydrochloride 10 MG/ML Ophthalmic SolutionSCDc53c8090-921f-45c5-bcd1-ce156ae3bb284
1298066cyclopentolate hydrochloride 1 % Ophthalmic SolutionSYc53c8090-921f-45c5-bcd1-ce156ae3bb284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3874-1500903874011 BOTTLE, DROPPER in 1 CARTON (50090-3874-1) > 15 mL in 1 BOTTLE, DROPPER2018-11-270000-00-00NoNoCurrent