Tropicamide

Product NDC: 61314-354
11-digit product format: 613140354
Labeler code: 61314
Product ID: 61314-354_2fbad93e-d3da-4a31-9a78-66a923ce78ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tropicamide
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA084305
Marketing category: ANDA
Marketing start: 2000-06-09
Substance: TROPICAMIDE
Active strength: 5 mg/mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	61314-354		D	Discontinued by firm		2026-08-03
excluded package	package	61314-354	61314-354-01	D	Discontinued by firm		2026-08-03

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 · 24 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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`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	61314-354-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A084305-001	MYDRIACYL	TROPICAMIDE	0.5%	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
A084305-001	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	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084305-001	MYDRIACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`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	A084305-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084305-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084305-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084305-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084305-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084305-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084305-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084305-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084305-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084305-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084305-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084305-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084305-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084305-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084305-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084305-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084305-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084305-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084305-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084305-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084305-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084305-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084305-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084305-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084305-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084305-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084305-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084305-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084305-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084305-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084305-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084305-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084305-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084305-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084305-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084305-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084305-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084305-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084305-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084305-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TROPICAMIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N0A3Z5XTC6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313521	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
521592d1-53a1-4314-8b3f-d808f3bccfcd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28c	Product name	2	20200603
41722ce4-2429-80d8-5977-d735f8eca6d6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61314-354-01	Tropicamide	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15		9
61314-354-01	Tropicamide	1 in 1 CARTON	SOLUTION/ DROPS	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-354-01	ML - Milliliter	61314-354	4f70189e-275a-4ad8-bed6-6bd4d9404790	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TROPICAMIDE	ACTIVE INGREDIENT	N0A3Z5XTC6	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
TROPICAMIDE	ACTIVE MOIETY	N0A3Z5XTC6	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TROPICAMIDE SOLUTION [SANDOZ INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TROPICAMIDE SOLUTION [SANDOZ INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-354	TROPICAMIDE SOLUTION/ DROPS [SANDOZ INC]	9	Current NDC, Legacy NDC, 2 package rows	20220309_521592d1-53a1-4314-8b3f-d808f3bccfcd.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
Tropicamide	TROPICAMIDE	Sandoz Inc	521592d1-53a1-4314-8b3f-d808f3bccfcd	2022-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084305 application number: ANDA084305 ndc (product): 61314-354

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N0A3Z5XTC6	TROPICAMIDE	1508-75-4	TROPICAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313521	tropicamide 0.5 % Ophthalmic Solution	PSN	521592d1-53a1-4314-8b3f-d808f3bccfcd	9
313521	tropicamide 5 MG/ML Ophthalmic Solution	SCD	521592d1-53a1-4314-8b3f-d808f3bccfcd	9
313521	tropicamide 0.5 % Ophthalmic Solution	SY	521592d1-53a1-4314-8b3f-d808f3bccfcd	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-354-01	61314035401	1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC	2000-06-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tropicamide Ophthalmic Solution, USP	REMEDYREPACK INC.	2022-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
Tropicamide Ophthalmic Solution, USP	Sandoz Inc	2022-01-26	HUMAN PRESCRIPTION DRUG LABEL	9