Cyclogyl

Product NDC: 0065-0397
11-digit product format: 000650397
Labeler code: 0065
Product ID: 0065-0397_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclopentolate hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: ANDA084108
Marketing category: ANDA
Marketing start: 1975-10-15
Substance: CYCLOPENTOLATE HYDROCHLORIDE
Active strength: 20 mg/mL
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
A084108-001	CYCLOGYL	CYCLOPENTOLATE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084108-001	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC		RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084108-001	CYCLOGYL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084108-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084108-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084108-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084108-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084108-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084108-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084108-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084108-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084108-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084108-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084108-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084108-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084108-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084108-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084108-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084108-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084108-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084108-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084108-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084108-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084108-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084108-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084108-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084108-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084108-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084108-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084108-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084108-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084108-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084108-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084108-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084108-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084108-001	AT	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclogyl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOPENTOLATE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
736I6971TE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298066	Internal RxNorm lookup
1298070	Internal RxNorm lookup
1298072	Internal RxNorm lookup
1298356	Internal RxNorm lookup
1298364	Internal RxNorm lookup
1298366	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1d008c76-7210-4ace-90fa-7cd22762e12e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0397-02	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-02	Cyclogyl	2 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2	15
0065-0397-05	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-05	Cyclogyl	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	15
0065-0397-15	Cyclogyl	1 in 1 CARTON	SOLUTION/ DROPS	1	15
0065-0397-15	Cyclogyl	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0397-02	ML - Milliliter	0065-0397	88c4d8b0-4c39-496e-9b38-dab434a1e2b2	1	2012-07-24
0065-0397-05	ML - Milliliter	0065-0397	c035097a-e837-4f04-b326-d65b141c1b1b	1	2012-07-24
0065-0397-15	ML - Milliliter	0065-0397	614df824-e4eb-409e-a365-f7eedbfb518b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOPENTOLATE HYDROCHLORIDE	ACTIVE INGREDIENT	736I6971TE	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
CYCLOPENTOLATE	ACTIVE MOIETY	I76F4SHP7J	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0397	CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	15	Current NDC, Legacy NDC, 6 package rows	20240627_1d008c76-7210-4ace-90fa-7cd22762e12e.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
Cyclogyl	CYCLOPENTOLATE HYDROCHLORIDE	Alcon Laboratories, Inc.	1d008c76-7210-4ace-90fa-7cd22762e12e	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084108 application number: ANDA084108 ndc (product): 0065-0397

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
1298366	Cyclogyl 0.5 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298356	Cyclogyl 1 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298364	Cyclogyl 2 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298072	cyclopentolate HCl 0.5 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298066	cyclopentolate HCl 1 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298070	cyclopentolate HCl 2 % Ophthalmic Solution	PSN	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298356	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298364	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298366	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution [Cyclogyl]	SBD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298066	cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution	SCD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298070	cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution	SCD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298072	cyclopentolate hydrochloride 5 MG/ML Ophthalmic Solution	SCD	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298366	Cyclogyl 0.5 % Ophthalmic Drops	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298356	Cyclogyl 1 % Ophthalmic Drops	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298356	Cyclogyl 10 MG/ML Ophthalmic Solution	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298364	Cyclogyl 2 % Ophthalmic Drops	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298364	Cyclogyl 20 MG/ML Ophthalmic Solution	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298366	Cyclogyl 5 MG/ML Ophthalmic Solution	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298072	cyclopentolate hydrochloride 0.5 % Ophthalmic Solution	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298066	cyclopentolate hydrochloride 1 % Ophthalmic Solution	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15
1298070	cyclopentolate hydrochloride 2 % Ophthalmic Drops	SY	1d008c76-7210-4ace-90fa-7cd22762e12e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0397-02	00065039702	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTIC	1975-10-15	0000-00-00	No	No	Current
0065-0397-05	00065039705	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-05) / 5 mL in 1 BOTTLE, PLASTIC	1975-10-15	0000-00-00	No	No	Current
0065-0397-15	00065039715	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-15) / 15 mL in 1 BOTTLE, PLASTIC	1975-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOGYL ® (cyclopentolate hydrochloride ophthalmic solution, USP)	Alcon Laboratories, Inc. \| Alcon Research LLC	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	15