Oxybutynin Chloride

Product NDC
62175-271
11-digit product format
621750271
Labeler code
62175
Product ID
62175-271_72bbc7a8-711b-47a6-8152-9409f4068929
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078503
Marketing category
ANDA
Marketing start
2009-03-01
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
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
A078503-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04
A078503-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04
A078503-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078503-001AB
A078503-002AB
A078503-003AB

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 UTC2026-02A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2009-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078503-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2009-02-048072bd15b7f6…

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 UTC2026-02A078503-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078503-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078503-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078503-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078503-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078503-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078503-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078503-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078503-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078503-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078503-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078503-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078503-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078503-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078503-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078503-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078503-001AB18072bd15b7f6…

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 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 · 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
c5950dba-d92b-46a0-993f-af9f9ddb52bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-271-37Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10042
62175-271-41Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE50042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-271-37EA - Each62175-271088a1b28-255d-4d12-8948-56fd0136d02412012-07-24
62175-271-41EA - Each62175-2715f389a63-1684-4a68-9e3a-4df23cca451812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK]4
Oxybutynin ChlorideACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
OxybutyninACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
anhydrous dextroseINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
tartaric acidINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-271OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]42Current NDC, Legacy NDC, 2 package rows20230629_c5950dba-d92b-46a0-993f-af9f9ddb52bf.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 Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAmerican Health Packaging0c71bdfb-01db-49ac-a8e9-0037df0d24af2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
oxybutynin chlorideOXYBUTYNIN CHLORIDEChartwell RX, LLCe464c8dd-5222-4a6b-b7e9-ca608a403c6e2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvKARE94471401-a516-0fe7-ec9c-447dd2bee9722025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.b5653b7e-1e3b-4da3-b3a2-33318f448c672025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvPAK242b4766-bc2b-0073-d72d-1bf879bbee242025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503
ndc (product): 62175-271
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078503
application number: ANDA078503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNb5653b7e-1e3b-4da3-b3a2-33318f448c6744
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDb5653b7e-1e3b-4da3-b3a2-33318f448c6744
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYb5653b7e-1e3b-4da3-b3a2-33318f448c6744
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYc5950dba-d92b-46a0-993f-af9f9ddb52bf42
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN0c71bdfb-01db-49ac-a8e9-0037df0d24af12
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD0c71bdfb-01db-49ac-a8e9-0037df0d24af12
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY0c71bdfb-01db-49ac-a8e9-0037df0d24af12
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN242b4766-bc2b-0073-d72d-1bf879bbee248
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD242b4766-bc2b-0073-d72d-1bf879bbee248
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY242b4766-bc2b-0073-d72d-1bf879bbee248
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN94471401-a516-0fe7-ec9c-447dd2bee9727
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD94471401-a516-0fe7-ec9c-447dd2bee9727
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY94471401-a516-0fe7-ec9c-447dd2bee9727
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN3272aaff-8d07-4be5-987f-ef3c5079a1332
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD3272aaff-8d07-4be5-987f-ef3c5079a1332
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY3272aaff-8d07-4be5-987f-ef3c5079a1332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-271-326217502713230 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-271-32) 2009-03-010000-00-00NoNoCurrent
62175-271-3762175027137100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-271-37) 2009-03-010000-00-00NoNoCurrent
62175-271-4162175027141500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-271-41) 2009-03-010000-00-00NoNoCurrent
62175-271-43621750271431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-271-43) 2009-03-010000-00-00NoNoCurrent