Oxybutynin Chloride

Product NDC
10702-201
11-digit product format
107020201
Labeler code
10702
Product ID
10702-201_289ec3ce-2fb1-608b-e063-6394a90a4a7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA209335
Marketing category
ANDA
Marketing start
2017-12-22
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209335-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209335-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209335-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209335-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209335-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209335-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209335-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209335-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209335-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209335-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209335-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209335-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209335-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209335-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209335-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209335-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209335-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209335-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209335-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209335-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209335-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209335-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209335-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209335-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209335-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209335-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209335-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209335-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209335-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209335-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209335-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209335-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209335-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209335-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209335-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209335-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209335-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209335-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209335-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209335-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209335-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209335-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-201-01Oxybutynin Chloride100 in 1 BOTTLE, PLASTICTABLET1008
10702-201-10Oxybutynin Chloride1000 in 1 BOTTLE, PLASTICTABLET10008
10702-201-50Oxybutynin Chloride500 in 1 BOTTLE, PLASTICTABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-201-01EA - Each10702-2017c0c70e2-2045-441a-96aa-7349b00cab7612018-02-20
10702-201-10EA - Each10702-201bc1919eb-c6af-4e8e-aad4-dbc502560d8012018-02-20
10702-201-50EA - Each10702-201b7445284-a886-4d44-90dc-623ac0313bcd12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-201OXYBUTYNIN CHLORIDE TABLET [KVK-TECH, INC.]8Current NDC, Legacy NDC, 3 package rows20241212_f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEREMEDYREPACK INC.1a08a16a-f16d-4ef1-95bb-6943bcae07372026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPreferred Pharmaceuticals Inc.0e002fe8-fa3f-4a7d-84df-0c6e031e6ae42026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLC13a79659-a181-6a61-e063-6294a90ae0342025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.9c8ced4b-94de-4df8-bea3-b42b8846b7692025-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.0c021aad-97a3-4404-a11e-cdd2ec731c6b2025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepackf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEKVK-Tech, Inc.f99fdfe8-a980-4a72-bc99-aa2ce0bdfd862024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
ndc (product): 10702-201
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0c021aad-97a3-4404-a11e-cdd2ec731c6b15
863664oxybutynin chloride 5 MG Oral TabletSCD0c021aad-97a3-4404-a11e-cdd2ec731c6b15
863664oxyBUTYnin chloride 5 MG Oral TabletPSN9c8ced4b-94de-4df8-bea3-b42b8846b76914
863664oxybutynin chloride 5 MG Oral TabletSCD9c8ced4b-94de-4df8-bea3-b42b8846b76914
863664oxyBUTYnin chloride 5 MG Oral TabletPSN39a2d144-0c10-4aec-9fa4-0adc24b332eb11
863664oxybutynin chloride 5 MG Oral TabletSCD39a2d144-0c10-4aec-9fa4-0adc24b332eb11
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxybutynin chloride 5 MG Oral TabletSCD1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf99fdfe8-a980-4a72-bc99-aa2ce0bdfd868
863664oxybutynin chloride 5 MG Oral TabletSCDf99fdfe8-a980-4a72-bc99-aa2ce0bdfd868
863664oxyBUTYnin chloride 5 MG Oral TabletPSNf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb5
863664oxybutynin chloride 5 MG Oral TabletSCDf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0e002fe8-fa3f-4a7d-84df-0c6e031e6ae44
863664oxybutynin chloride 5 MG Oral TabletSCD0e002fe8-fa3f-4a7d-84df-0c6e031e6ae44
863664oxyBUTYnin chloride 5 MG Oral TabletPSN13a79659-a181-6a61-e063-6294a90ae0342
863664oxybutynin chloride 5 MG Oral TabletSCD13a79659-a181-6a61-e063-6294a90ae0342
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8189da24-31df-428f-bae5-b249779a90571
863664oxybutynin chloride 5 MG Oral TabletSCD8189da24-31df-428f-bae5-b249779a90571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-201-0110702020101100 TABLET in 1 BOTTLE, PLASTIC (10702-201-01) 100 tablet2017-12-220000-00-00NoNoCurrent
10702-201-10107020201101000 TABLET in 1 BOTTLE, PLASTIC (10702-201-10) 1000 tablet2017-12-220000-00-00NoNoCurrent
10702-201-5010702020150500 TABLET in 1 BOTTLE, PLASTIC (10702-201-50) 500 tablet2017-12-220000-00-00NoNoCurrent