Oxybutynin Chloride

Product NDC: 68084-610
11-digit product format: 680840610
Labeler code: 68084
Product ID: 68084-610_230831a1-53bb-f16b-e063-6394a90ab9df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA078503
Marketing category: ANDA
Marketing start: 2012-12-12
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078503-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04
A078503-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04
A078503-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078503-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078503-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078503-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078503-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078503-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078503-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078503-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078503-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078503-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078503-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078503-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078503-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078503-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078503-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078503-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078503-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078503-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078503-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078503-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078503-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078503-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxybutynin Chloride
Brand name suffix: Extended Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN CHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L9F3D9RENQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c71bdfb-01db-49ac-a8e9-0037df0d24af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
3544f362-07fc-93b1-457b-1fba00be087a	Product name	8	20230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4	Product name	8	20210525
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
982338c6-c45c-b6b4-1452-14b01fbdf98d	Product name	2	20180801
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6	Product name	2	20171212
3544f362-07fc-93b1-457b-1fba00be087a	Product name	2	20171212
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
8b00ae7e-01f2-f83c-632e-edfc23808364	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-610-11	Oxybutynin ChlorideExtended Release	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		12
68084-610-21	Oxybutynin ChlorideExtended Release	30 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-610-11	EA - Each	68084-610	148a32c2-5781-4043-afea-514c262d7313	1	2013-02-13
68084-610-21	EA - Each	68084-610	47bc9a0c-f7a5-401b-a647-0792a3c2c949	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-610	OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	12	Current NDC, Legacy NDC, 2 package rows	20240929_0c71bdfb-01db-49ac-a8e9-0037df0d24af.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	American Health Packaging	0c71bdfb-01db-49ac-a8e9-0037df0d24af	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503 ndc (product): 68084-610
oxybutynin chloride	OXYBUTYNIN CHLORIDE	Chartwell RX, LLC	e464c8dd-5222-4a6b-b7e9-ca608a403c6e	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	AvKARE	94471401-a516-0fe7-ec9c-447dd2bee972	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	b5653b7e-1e3b-4da3-b3a2-33318f448c67	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	AvPAK	242b4766-bc2b-0073-d72d-1bf879bbee24	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Lannett Company, Inc.	c5950dba-d92b-46a0-993f-af9f9ddb52bf	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e985e201-2fb3-4781-9790-a1a3db1ae2a1	2017-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078503 application number: ANDA078503

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L9F3D9RENQ	OXYBUTYNIN CHLORIDE	1508-65-2	OXYBUTYNIN CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863619	oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet	PSN	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12
863636	oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet	PSN	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12
863619	24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet	SCD	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12
863636	24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet	SCD	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12
863619	oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet	SY	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12
863636	oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet	SY	0c71bdfb-01db-49ac-a8e9-0037df0d24af	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-610-11	68084061011	1 in 1 BLISTER PACK						Historical
68084-610-21	68084061021	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-610-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-610-11)	30 blister pack	2012-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Extended Release	American Health Packaging	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	13