FDA.reportPublic FDA data

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

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

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