Betaxolol

Product NDC
42806-038
11-digit product format
428060038
Labeler code
42806
Product ID
42806-038_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA075541
Marketing category
ANDA
Marketing start
2010-07-20
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075541-001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22
A075541-002BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075541-001AB
A075541-002AB

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 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-01-19 17:59 UTC2025-01A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-2203ed91905a0d…
2025-01-19 17:59 UTC2025-01A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-228869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-22c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075541-001BETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB1999-10-223f01610625f2…
2019-12-14 00:12 UTC2019-12A075541-002BETAXOLOL HYDROCHLORIDE20MGTABLET / ORALABRS1999-10-223f01610625f2…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC2025-01A075541-001AB103ed91905a0d…
2025-01-19 17:59 UTC2025-01A075541-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075541-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075541-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075541-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075541-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075541-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075541-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075541-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075541-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075541-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075541-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075541-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075541-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075541-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075541-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075541-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075541-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075541-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075541-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075541-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075541-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075541-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075541-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075541-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075541-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075541-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075541-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075541-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075541-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075541-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075541-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075541-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075541-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075541-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075541-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075541-002AB13f01610625f2…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BetaxololBETAXOLOLEpic Pharma LLCbf716efe-0a9f-43b1-9d8a-c69330b82e182023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075541
application number: ANDA075541
ndc (product): 42806-038
BetaxololBETAXOLOLPuraCap Laboratories LLCe198244d-fda3-4015-8c01-390f3f88e2382019-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075541
application number: ANDA075541

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAXOLOL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6X97D2XT0OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1297753Internal RxNorm lookup
1297757Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf716efe-0a9f-43b1-9d8a-c69330b82e18Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-038-01Betaxolol100 in 1 BOTTLETABLET, FILM COATED10012
42806-038-10Betaxolol1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-038-01EA - Each42806-038511bd906-9897-4352-9259-9dc4e08a416912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBETAXOLOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-038BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]12Current NDC, Legacy NDC, 2 package rows20241222_bf716efe-0a9f-43b1-9d8a-c69330b82e18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297753betaxolol HCl 10 MG Oral TabletPSNbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol HCl 20 MG Oral TabletPSNbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297753betaxolol hydrochloride 10 MG Oral TabletSCDbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol hydrochloride 20 MG Oral TabletSCDbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol hydrochloride (betaxolol 17.88 MG) Oral TabletSYbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSYbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297753betaxolol HCl 10 MG Oral TabletPSN94fa6c50-de10-4c07-a668-1880061561cc2
1297753betaxolol hydrochloride 10 MG Oral TabletSCD94fa6c50-de10-4c07-a668-1880061561cc2
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSY94fa6c50-de10-4c07-a668-1880061561cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-038-0142806003801100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01) 2010-07-200000-00-00NoNoCurrent
42806-038-10428060038101000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10) 2010-07-200000-00-00NoNoCurrent