Oxybutynin Chloride

Product NDC
64980-209
11-digit product format
649800209
Labeler code
64980
Product ID
64980-209_6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206121
Marketing category
ANDA
Marketing start
2016-09-27
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206121-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27
A206121-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27
A206121-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206121-001AB
A206121-002AB
A206121-003AB

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 UTC2026-02A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2016-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206121-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-05-278072bd15b7f6…

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 UTC2026-02A206121-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206121-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206121-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206121-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206121-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206121-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206121-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206121-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206121-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206121-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206121-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206121-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206121-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206121-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206121-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206121-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206121-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206121-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206121-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206121-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863619Internal RxNorm lookup
863628Internal RxNorm lookup
863636Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab431781-3183-4638-b656-f40a61f07940Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-209-01Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
64980-209-03Oxybutynin ChlorideExtended Release30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
64980-209-05Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-209-01EA - Each64980-2095254f71a-1169-4744-ac01-4c1cd598b32a12016-12-07
64980-209-05EA - Each64980-209e3b410a5-37e6-4678-a7a1-818038fc201012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-209OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]11Current NDC, Legacy NDC, 3 package rows20230707_ab431781-3183-4638-b656-f40a61f07940.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutionsb9d0e5c8-3a71-40a0-a7d3-44bc043392fa2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutions3688227b-7655-40ca-b34b-073a39fd60f42026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.e466d963-469a-4b1c-87f9-2e3e1e9bdf3d2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDERising Pharma Holdings, Inc.ab431781-3183-4638-b656-f40a61f079402025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
ndc (product): 64980-209
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack2f898b29-46cf-4427-bb64-8c30532222f52024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206121
application number: ANDA206121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN2f898b29-46cf-4427-bb64-8c30532222f5100
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD2f898b29-46cf-4427-bb64-8c30532222f5100
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY2f898b29-46cf-4427-bb64-8c30532222f5100
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-209-0164980020901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-01) 2016-09-270000-00-00NoNoCurrent
64980-209-036498002090330 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-03) 2022-03-290000-00-00NoNoCurrent
64980-209-0564980020905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-05) 2022-03-290000-00-00NoNoCurrent