FDA.reportPublic FDA data

Betoptic S

Product NDC
0078-0729
11-digit product format
000780729
Labeler code
0078
Product ID
0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betaxolol hydrochloride
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA019845
Marketing category
NDA
Marketing start
1996-01-15
Marketing end
2026-11-30
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
2.8 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Betoptic S

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAXOLOL HYDROCHLORIDE2.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6X97D2XT0O
Rxcui213729, 308719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0729-10Betoptic S1 in 1 CARTONSUSPENSION/ DROPS14
0078-0729-10Betoptic S10 mL in 1 BOTTLESUSPENSION/ DROPS104
0078-0729-15Betoptic S15 mL in 1 BOTTLESUSPENSION/ DROPS154
0078-0729-15Betoptic S1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0729-10ML - Milliliter0078-0729e4dfda8f-1404-49ae-a6e9-b2e4839fa4f312023-01-09
0078-0729-15ML - Milliliter0078-0729571a3503-9f2e-4caf-99d6-06ee4484f3b312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0729BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]4Current NDC, Legacy NDC, 4 package rows20250123_905ba189-456c-4aa4-8231-39a971374ad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308719betaxolol HCl 0.25 % Ophthalmic SuspensionPSN905ba189-456c-4aa4-8231-39a971374ad84
213729Betoptic S 0.25 % Ophthalmic SuspensionPSN905ba189-456c-4aa4-8231-39a971374ad84
213729betaxolol 2.5 MG/ML Ophthalmic Suspension [Betoptic S]SBD905ba189-456c-4aa4-8231-39a971374ad84
308719betaxolol 2.5 MG/ML Ophthalmic SuspensionSCD905ba189-456c-4aa4-8231-39a971374ad84
308719betaxolol 0.25 % Ophthalmic SuspensionSY905ba189-456c-4aa4-8231-39a971374ad84
308719betaxolol 2.5 MG/ML (betaxolol hydrochloride 2.8 MG/ML) Ophthalmic SuspensionSY905ba189-456c-4aa4-8231-39a971374ad84
213729Betoptic S 0.25 % Ophthalmic SuspensionSY905ba189-456c-4aa4-8231-39a971374ad84
213729Betoptic S 2.5 MG/ML (betaxolol hydrochloride 2.8 MG/ML) Ophthalmic SuspensionSY905ba189-456c-4aa4-8231-39a971374ad84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0729-10000780729101 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE1 bottle2022-08-032026-11-30NoNoCurrent
0078-0729-15000780729151 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE1 bottle2022-08-032026-11-30NoNoCurrent