Mydriacyl

Product NDC
0998-0355
11-digit product format
009980355
Labeler code
0998
Product ID
0998-0355_86af6085-d52b-4516-8234-64ae8baa98b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tropicamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
ANDA084306
Marketing category
ANDA
Marketing start
1959-04-01
Substance
TROPICAMIDE
Active strength
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084306-001MYDRIACYLTROPICAMIDE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084306-001AT

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 UTC2026-02A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084306-001MYDRIACYL1%SOLUTION/DROPS / OPHTHALMICATRLD, RS, Approved before 1982cb3db0bc1861…

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 UTC2026-02A084306-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084306-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084306-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084306-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084306-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084306-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084306-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084306-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084306-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084306-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084306-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084306-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084306-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084306-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084306-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084306-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084306-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084306-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084306-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084306-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084306-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A084306-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084306-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084306-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084306-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A084306-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084306-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084306-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084306-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084306-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084306-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084306-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084306-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084306-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084306-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084306-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084306-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084306-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084306-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084306-001AT1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROPICAMIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N0A3Z5XTC6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
208660Internal RxNorm lookup
314238Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d4f4a2e-eb00-4c65-b3fa-baf5738d468dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28cProduct name220200603
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
41722ce4-2429-80d8-5977-d735f8eca6d6Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0998-0355-15Mydriacyl15 mL in 1 BOTTLESOLUTION/ DROPS159
0998-0355-15Mydriacyl1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0355-15ML - Milliliter0998-03558165cf5c-6b49-43ff-8d41-63bcdccf95f012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0998-0355MYDRIACYL (TROPICAMIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]9Current NDC, Legacy NDC, 2 package rows20230217_0d4f4a2e-eb00-4c65-b3fa-baf5738d468d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MydriacylTROPICAMIDEAlcon Laboratories, Inc.0d4f4a2e-eb00-4c65-b3fa-baf5738d468d2023-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084306
application number: ANDA084306
ndc (product): 0998-0355
MydriacylTROPICAMIDEAlcon Laboratories, Inc.57165763-29dc-4812-b840-a8a5086416f32022-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084306
application number: ANDA084306
TropicamideTROPICAMIDESandoz Inc0104ffe4-013d-4afa-996d-dcba4f08e93d2022-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084306
application number: ANDA084306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208660Mydriacyl 1 % Ophthalmic SolutionPSN0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
314238tropicamide 1 % Ophthalmic SolutionPSN0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
208660tropicamide 10 MG/ML Ophthalmic Solution [Mydriacyl]SBD0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
314238tropicamide 10 MG/ML Ophthalmic SolutionSCD0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
208660Mydriacyl 1 % Ophthalmic SolutionSY0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
208660Mydriacyl 10 MG/ML Ophthalmic SolutionSY0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9
314238tropicamide 1 % Ophthalmic SolutionSY0d4f4a2e-eb00-4c65-b3fa-baf5738d468d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0998-0355-15009980355151 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE1 bottle1959-04-010000-00-00NoNoCurrent