DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE

Product NDC
70377-082
11-digit product format
703770082
Labeler code
70377
Product ID
70377-082_46ba7958-0844-4809-b1e4-2bbb5fa86459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dorzolamide hydrochloride timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Biocon Pharma Inc.
Application
ANDA202054
Marketing category
ANDA
Marketing start
2022-01-08
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct70377-082IInactivated by FDA2026-08-11
excluded packagepackage70377-08270377-082-11IInactivated by FDA2026-08-11

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
A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202054-001AT1

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 UTC2026-02A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-033f01610625f2…
2019-09-15 20:21 UTC2019-09A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2014-09-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202054-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2014-09-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202054-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202054-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202054-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202054-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202054-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202054-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202054-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202054-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202054-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202054-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202054-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202054-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202054-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202054-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202054-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202054-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202054-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A202054-001AT1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202054-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202054-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202054-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202054-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202054-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202054-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202054-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A202054-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202054-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202054-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202054-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202054-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202054-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202054-001AT11a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
973dd458-49b1-1bb1-62c6-b37c4b15fe1fProduct name520251121
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70377-082-11DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS12
70377-082-11DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-082-11ML - Milliliter70377-08204f0dd06-eb1f-4cf9-a31f-ea106355b5a712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-082DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE SOLUTION/ DROPS [BIOCON PHARMA INC.]2Legacy NDC, 2 package rows20220113_6b20c356-5f80-4cb9-87d0-02abd24b623c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC02d89d37-cbca-4e06-83ef-2a10f988f1ea2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202054
application number: ANDA202054
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAEDDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEIndoco Remedies Limited0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202054
application number: ANDA202054

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSN6b20c356-5f80-4cb9-87d0-02abd24b623c2
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD6b20c356-5f80-4cb9-87d0-02abd24b623c2
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSY6b20c356-5f80-4cb9-87d0-02abd24b623c2
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSY6b20c356-5f80-4cb9-87d0-02abd24b623c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-082-11703770082111 BOTTLE, DISPENSING in 1 CARTON (70377-082-11) > 10 mL in 1 BOTTLE, DISPENSING2022-01-080000-00-00NoNoCurrent