FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71335-1690
11-digit product format
713351690
Labeler code
71335
Product ID
71335-1690_b96b1e58-04f2-40be-9b7d-03209475cc2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211655
Marketing category
ANDA
Marketing start
2019-02-28
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211655-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28
A211655-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28
A211655-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211655-001AB
A211655-002AB
A211655-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2019-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2019-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211655-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2019-02-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211655-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211655-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211655-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211655-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211655-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211655-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211655-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211655-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211655-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211655-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211655-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211655-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211655-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211655-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211655-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211655-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211655-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211655-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211655-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211655-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L9F3D9RENQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863619Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5965c8b-179d-4665-8a3b-324b693607eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1690-1Oxybutynin Chloride30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-1690-2Oxybutynin Chloride18 in 1 BOTTLETABLET, EXTENDED RELEASE185
71335-1690-3Oxybutynin Chloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-1690-4Oxybutynin Chloride60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1690OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 4 package rows20240524_a5965c8b-179d-4665-8a3b-324b693607ee.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepacka5965c8b-179d-4665-8a3b-324b693607ee2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211655
application number: ANDA211655
ndc (product): 71335-1690
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC3f7dc283-b168-8251-e063-6294a90a45a22025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211655
application number: ANDA211655
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC3f7da2a3-ca46-d3e8-e063-6294a90abef32025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211655
application number: ANDA211655
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAjanta Pharma USA Inc.95c2a144-ba0d-4011-ae0f-0e0ca876e8a82025-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211655
application number: ANDA211655

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNa5965c8b-179d-4665-8a3b-324b693607ee5
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDa5965c8b-179d-4665-8a3b-324b693607ee5
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYa5965c8b-179d-4665-8a3b-324b693607ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1690-17133516900130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-1) 2021-12-290000-00-00NoNoCurrent
71335-1690-27133516900218 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-2) 2021-12-290000-00-00NoNoCurrent
71335-1690-37133516900390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-3) 2020-08-110000-00-00NoNoCurrent
71335-1690-47133516900460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1690-4) 2021-12-290000-00-00NoNoCurrent