FDA.reportPublic FDA data

Betimol

Product NDC
76478-002
11-digit product format
764780002
Labeler code
76478
Product ID
76478-002_1148d491-87d2-4423-8486-4e5355e968ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA020439
Marketing category
NDA
Marketing start
2014-01-02
Marketing end
0000-00-00
Substance
TIMOLOL
Active strength
5 mg/mL
Pharmacologic classes
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76478-002-052024-01-30C16284748780-11030e364-f9db-111a-e063-dadaa90a10e2BETIMOL ®
76478-002-102024-01-30C16284748780-11030e364-f9db-111a-e063-dadaa90a10e2BETIMOL ®
76478-002-122024-01-30C16284748780-11030e364-f9db-111a-e063-dadaa90a10e2BETIMOL ®
76478-002-152024-01-30C16284748780-11030e364-f9db-111a-e063-dadaa90a10e2BETIMOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76478-002-05Betimol5 mL in 1 BOTTLESOLUTION/ DROPS55
76478-002-05Betimol1 in 1 CARTONSOLUTION/ DROPS15
76478-002-10Betimol1 in 1 CARTONSOLUTION/ DROPS15
76478-002-10Betimol10 mL in 1 BOTTLESOLUTION/ DROPS105
76478-002-12Betimol1 in 1 CARTONSOLUTION/ DROPS15
76478-002-12Betimol2.5 mL in 1 BOTTLESOLUTION/ DROPS2.55
76478-002-15Betimol1 in 1 CARTONSOLUTION/ DROPS15
76478-002-15Betimol15 mL in 1 BOTTLESOLUTION/ DROPS155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76478-002-05ML - Milliliter76478-0020e723401-d460-4b7a-96af-0553acabea7512014-04-03
76478-002-10ML - Milliliter76478-0027ef84e89-594c-4b5d-9521-791429888ce112014-04-03
76478-002-15ML - Milliliter76478-0020ddb0ef1-bba6-4106-bbe6-ffa3ae984e4212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TimololACTIVE INGREDIENT817W3C6175BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1
Timolol AnhydrousACTIVE MOIETY5JKY92S7BRBETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1
sodium phosphate, dibasic, dihydrateINACTIVE INGREDIENT94255I6E2TBETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956BETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1
waterINACTIVE INGREDIENT059QF0KO0RBETIMOL (TIMOLOL) SOLUTION/ DROPS [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) (968937719)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76478-002BETIMOL (TIMOLOL) SOLUTION/ DROPS [AKORN]5Legacy NDC, 8 package rows20220503_3d7acd55-33b1-4a24-99ae-01f87b0dca1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208560BETIMOL 0.25 % Ophthalmic SolutionPSN3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
1992305BETIMOL 0.5 % Ophthalmic SolutionPSN3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702398timolol hemihydrate 0.25 % Ophthalmic SolutionPSN3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702393timolol hemihydrate 0.5 % Ophthalmic SolutionPSN3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
208560timolol hemihydrate 2.5 MG/ML Ophthalmic Solution [Betimol]SBD3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
1992305timolol hemihydrate 5 MG/ML Ophthalmic Solution [Betimol]SBD3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702398timolol hemihydrate 2.5 MG/ML Ophthalmic SolutionSCD3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702393timolol hemihydrate 5 MG/ML Ophthalmic SolutionSCD3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
208560Betimol 0.25 % Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
1992305Betimol 0.5 % Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
208560Betimol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
208560Betimol 2.5 MG/ML Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
1992305Betimol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702398timolol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5
2702393timolol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic SolutionSY3d7acd55-33b1-4a24-99ae-01f87b0dca1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76478-002-05764780002051 BOTTLE in 1 CARTON (76478-002-05) > 5 mL in 1 BOTTLE1 bottle2014-01-020000-00-00NoNoCurrent
76478-002-10764780002101 BOTTLE in 1 CARTON (76478-002-10) > 10 mL in 1 BOTTLE1 bottle2014-01-020000-00-00NoNoCurrent
76478-002-12764780002121 BOTTLE in 1 CARTON (76478-002-12) > 2.5 mL in 1 BOTTLE1 bottle2014-01-020000-00-00YesNoCurrent
76478-002-15764780002151 BOTTLE in 1 CARTON (76478-002-15) > 15 mL in 1 BOTTLE1 bottle2014-01-020000-00-00NoNoCurrent