Dorzolamide Hydrochloride

Product NDC
70377-081
11-digit product format
703770081
Labeler code
70377
Product ID
70377-081_56fdb140-a79c-468a-80b4-88e846618064
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Biocon Pharma Inc.
Application
ANDA202053
Marketing category
ANDA
Marketing start
2022-01-08
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]
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
973dd458-49b1-1bb1-62c6-b37c4b15fe1fProduct name520251121
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70377-081-11Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS12
70377-081-11Dorzolamide Hydrochloride10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-081-11ML - Milliliter70377-08103def2f6-d194-4a95-84fa-d8069a9a01d812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-081DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) SOLUTION/ DROPS [BIOCON PHARMA INC.]2Legacy NDC, 2 package rows20220113_9bc35df4-2d41-4160-8dae-7eea3e4ff0ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN9bc35df4-2d41-4160-8dae-7eea3e4ff0ce2
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD9bc35df4-2d41-4160-8dae-7eea3e4ff0ce2
310015dorzolamide 2 % Ophthalmic SolutionSY9bc35df4-2d41-4160-8dae-7eea3e4ff0ce2
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY9bc35df4-2d41-4160-8dae-7eea3e4ff0ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-081-11703770081111 BOTTLE, DISPENSING in 1 CARTON (70377-081-11) > 10 mL in 1 BOTTLE, DISPENSING2022-01-080000-00-00NoNoCurrent