NDC 76519-1163

TIMOLOL MALEATE

Timolol Maleate

TIMOLOL MALEATE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Timolol Maleate.

Product ID76519-1163_92c79a2d-f3b7-236b-e053-2a95a90a06a7
NDC76519-1163
Product TypeHuman Prescription Drug
Proprietary NameTIMOLOL MALEATE
Generic NameTimolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-11-02
Marketing CategoryANDA / ANDA
Application NumberANDA077259
Labeler NameH.J. Harkins Company, Inc.
Substance NameTIMOLOL MALEATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76519-1163-0

5 mL in 1 BOTTLE (76519-1163-0)
Marketing Start Date2018-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1163-0 [76519116300]

TIMOLOL MALEATE SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077259
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-02

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE.1 mg/mL

OpenFDA Data

SPL SET ID:92c79a2d-f3b6-236b-e053-2a95a90a06a7
Manufacturer
UNII

Pharmacological Class

  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]
  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "TIMOLOL MALEATE" or generic name "Timolol Maleate"

NDCBrand NameGeneric Name
0378-0055Timolol Maleatetimolol maleate
0378-0221Timolol Maleatetimolol maleate
0378-0715Timolol Maleatetimolol maleate
13811-618Timolol MaleateTimolol Maleate
13811-619Timolol MaleateTimolol Maleate
13811-620Timolol MaleateTimolol Maleate
17478-189Timolol MaleateTimolol
17478-288Timolol MaleateTimolol Maleate
17478-289Timolol MaleateTimolol Maleate
17478-365Timolol MaleateTimolol
17478-366Timolol MaleateTimolol
67877-229Timolol MaleateTimolol Maleate
68071-1563Timolol MaleateTimolol Maleate
68071-1558TIMOLOL MALEATETIMOLOL MALEATE
68682-045Timolol MaleateTimolol Maleate
69189-0496Timolol MaleateTimolol Maleate
70518-1211Timolol MaleateTimolol Maleate
24208-818Timolol MaleateTimolol Maleate
24208-819Timolol MaleateTimolol Maleate
50090-1852TIMOLOL MALEATETIMOLOL MALEATE
50383-021Timolol MaleateTimolol Maleate
50090-3441Timolol MaleateTimolol Maleate
55545-1000TIMOLOL MALEATETIMOLOL MALEATE
55545-1001TIMOLOL MALEATETIMOLOL MALEATE
60505-1005Timolol MaleateTimolol Maleate
60758-801TIMOLOL MALEATETIMOLOL MALEATE
61314-227Timolol MaleateTimolol Maleate
60758-802TIMOLOL MALEATETIMOLOL MALEATE
61314-226Timolol MaleateTimolol Maleate
63629-7167Timolol MaleateTimolol Maleate
64980-514TIMOLOL MALEATETIMOLOL MALEATE
64980-513TIMOLOL MALEATETIMOLOL MALEATE
70518-2354TIMOLOL MALEATETIMOLOL MALEATE
70518-2353TIMOLOL MALEATETIMOLOL MALEATE
76519-1163TIMOLOL MALEATETIMOLOL MALEATE
24208-004IstalolTimolol Maleate
0187-1496Timoptic in OcudoseTimolol Maleate
0187-1498Timoptic in OcudoseTimolol Maleate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.