Timolol Maleate

Product NDC
0378-0715
Requested package NDC
0378-0715-01
11-digit product format
003780715
Labeler code
0378
Product ID
0378-0715_96dd25ab-c0a7-47e6-b056-c53813615d36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA072668
Marketing category
ANDA
Marketing start
1990-06-08
Marketing end
0000-00-00
Substance
TIMOLOL MALEATE
Active strength
20 mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0378-07150378-0715-01DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072668-001TIMOLOL MALEATETIMOLOL MALEATE20MGTABLET / ORAL1990-06-08
A072668-002TIMOLOL MALEATETIMOLOL MALEATE5MGTABLET / ORAL1990-06-08
A072668-003TIMOLOL MALEATETIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072668-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072668-001TIMOLOL MALEATE20MGTABLET / ORAL1990-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A072668-002TIMOLOL MALEATE5MGTABLET / ORAL1990-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-002TIMOLOL MALEATE5MGTABLET / ORALAB1990-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-003TIMOLOL MALEATE10MGTABLET / ORALAB1990-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-001TIMOLOL MALEATE20MGTABLET / ORALABRS1990-06-081e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A072668-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072668-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072668-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072668-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072668-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072668-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072668-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072668-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072668-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072668-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072668-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072668-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072668-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072668-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072668-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072668-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072668-003AB11e350fbaab3a…

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
0378-0715-01Timolol Maleate100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0715-01EA - Each0378-07152102c6f9-65d4-45ca-8c88-f18ad23de7ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0715TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]10Legacy NDC, 1 package rows20250522_57c62928-63d8-4505-9b9e-c085a3a12c95.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATEMylan Pharmaceuticals Inc.57c62928-63d8-4505-9b9e-c085a3a12c952020-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072668
application number: ANDA072668
ndc (package): 0378-0715-01
ndc (product): 0378-0715
ndc11 (package): 00378071501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198284timolol maleate 10 MG Oral TabletPSN57c62928-63d8-4505-9b9e-c085a3a12c9510
198285timolol maleate 20 MG Oral TabletPSN57c62928-63d8-4505-9b9e-c085a3a12c9510
198286timolol maleate 5 MG Oral TabletPSN57c62928-63d8-4505-9b9e-c085a3a12c9510
198284timolol 10 MG Oral TabletSCD57c62928-63d8-4505-9b9e-c085a3a12c9510
198285timolol 20 MG Oral TabletSCD57c62928-63d8-4505-9b9e-c085a3a12c9510
198286timolol 5 MG Oral TabletSCD57c62928-63d8-4505-9b9e-c085a3a12c9510
198284timolol 10 MG (as maleate) Oral TabletSY57c62928-63d8-4505-9b9e-c085a3a12c9510
198285timolol 20 MG (as maleate) Oral TabletSY57c62928-63d8-4505-9b9e-c085a3a12c9510
198286timolol 5 MG (as maleate) Oral TabletSY57c62928-63d8-4505-9b9e-c085a3a12c9510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0715-0100378071501100 TABLET in 1 BOTTLE, PLASTIC (0378-0715-01) 100 tablet1990-06-080000-00-00NoNoCurrent