Cyclopentolate Hydrochloride

Product NDC: 42254-013
11-digit product format: 422540013
Labeler code: 42254
Product ID: 42254-013_4d4131f8-79d0-40a4-87e8-667fd2db8d7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclopentolate Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: ANDA040075
Marketing category: ANDA
Marketing start: 1994-04-29
Marketing end: 0000-00-00
Substance: CYCLOPENTOLATE HYDROCHLORIDE
Active strength: 10 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-013		I	Inactivated by FDA		2026-08-10
excluded package	package	42254-013	42254-013-15	I	Inactivated by FDA		2026-08-10

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-013-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-013-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-013-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-013-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-013-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-013-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-013-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-013-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-013-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-013-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-013-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-013-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-013-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-013-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-013-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-013-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-013-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-013-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-013-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-013-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-013-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-013-15	`110d247fa046…`	`a55b01930146…`

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
A040075-001	PENTOLAIR	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040075-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040075-001	PENTOLAIR	1%	SOLUTION/DROPS / OPHTHALMIC	AT	1994-04-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040075-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040075-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040075-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040075-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040075-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040075-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040075-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040075-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040075-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040075-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040075-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040075-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040075-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040075-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040075-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040075-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040075-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040075-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040075-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040075-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040075-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040075-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040075-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040075-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040075-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040075-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040075-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040075-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040075-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040075-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040075-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040075-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040075-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040075-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040075-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040075-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040075-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040075-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040075-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040075-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
da26936b-2875-4173-812f-99a1f7074052	Product name	1	20151215
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-013-15	2019-09-24	C162847	48780-1	9350213a-3c35-c013-e053-90daa90a1393	Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-013-15	Cyclopentolate Hydrochloride	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		1
42254-013-15	Cyclopentolate Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-013-15	ML - Milliliter	42254-013	243fae13-6ade-4053-aa53-c6d349de4111	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOPENTOLATE HYDROCHLORIDE	ACTIVE INGREDIENT	736I6971TE	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
CYCLOPENTOLATE	ACTIVE MOIETY	I76F4SHP7J	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-013	CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20111208_4d4131f8-79d0-40a4-87e8-667fd2db8d7a.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclopentolate Hydrochloride	CYCLOPENTOLATE HYDROCHLORIDE	Bausch & Lomb Incorporated	ad85b220-6003-4a78-b900-5195ceaf0fd5	2022-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040075 application number: ANDA040075

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
736I6971TE	CYCLOPENTOLATE HYDROCHLORIDE	5870-29-1	CYCLOPENTOLATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298066	cyclopentolate HCl 1 % Ophthalmic Solution	PSN	4d4131f8-79d0-40a4-87e8-667fd2db8d7a	1
1298066	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution	SCD	4d4131f8-79d0-40a4-87e8-667fd2db8d7a	1
1298066	cyclopentolate hydrochloride 1 % Ophthalmic Solution	SY	4d4131f8-79d0-40a4-87e8-667fd2db8d7a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42254-013-15	42254001315	15 mL in 1 BOTTLE, DROPPER	15 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% (Sterile)	Rebel Distributors Corp	2011-10-25	HUMAN PRESCRIPTION DRUG LABEL	1