FDA.reportPublic FDA data

BETIMOL

Product NDC
82584-001
11-digit product format
825840001
Labeler code
82584
Product ID
82584-001_3891d7f3-d858-9f71-e063-6394a90af95b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Thea Pharma Inc.
Application
NDA020439
Marketing category
NDA
Marketing start
2022-12-01
Substance
TIMOLOL
Active strength
2.56 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL2.56 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii817W3C6175
Rxcui208560, 1992305, 2702393, 2702398

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-001-05BETIMOL1 in 1 CARTONSOLUTION/ DROPS16
82584-001-05BETIMOL5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-001-05ML - Milliliter82584-0018764d6b1-5eba-436d-ae78-5a6b967ae6a012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-001BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20240430_3ae775f4-340c-4bf4-aa49-8a31daba0f8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208560BETIMOL 0.25 % Ophthalmic SolutionPSN3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
1992305BETIMOL 0.5 % Ophthalmic SolutionPSN3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702398timolol hemihydrate 0.25 % Ophthalmic SolutionPSN3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702393timolol hemihydrate 0.5 % Ophthalmic SolutionPSN3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
208560timolol hemihydrate 2.5 MG/ML Ophthalmic Solution [Betimol]SBD3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
1992305timolol hemihydrate 5 MG/ML Ophthalmic Solution [Betimol]SBD3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702398timolol hemihydrate 2.5 MG/ML Ophthalmic SolutionSCD3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702393timolol hemihydrate 5 MG/ML Ophthalmic SolutionSCD3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
208560Betimol 0.25 % Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
1992305Betimol 0.5 % Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
208560Betimol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
208560Betimol 2.5 MG/ML Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
1992305Betimol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702398timolol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6
2702393timolol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic SolutionSY3ae775f4-340c-4bf4-aa49-8a31daba0f8b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82584-001-05825840001051 BOTTLE, DROPPER in 1 CARTON (82584-001-05) > 5 mL in 1 BOTTLE, DROPPER2022-12-010000-00-00NoNoCurrent