Oxybutynin Chloride

Product NDC: 65162-372
11-digit product format: 651620372
Labeler code: 65162
Product ID: 65162-372_25b959bc-5b59-4c9c-b7a0-ae475a8e0290
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA204010
Marketing category: ANDA
Marketing start: 2015-11-02
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
A204010-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23
A204010-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23
A204010-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204010-001	AB
A204010-002	AB
A204010-003	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	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`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	A204010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204010-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxybutynin Chloride
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863619	Internal RxNorm lookup
863628	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
53924eba-1919-4203-9a1e-d57dfdd3b963	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3544f362-07fc-93b1-457b-1fba00be087a	Product name	8	20230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4	Product name	8	20210525
982338c6-c45c-b6b4-1452-14b01fbdf98d	Product name	2	20180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6	Product name	2	20171212
3544f362-07fc-93b1-457b-1fba00be087a	Product name	2	20171212
8b00ae7e-01f2-f83c-632e-edfc23808364	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-372-03	Oxybutynin Chloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	19
65162-372-09	Oxybutynin Chloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	19
65162-372-10	Oxybutynin Chloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	19
65162-372-50	Oxybutynin Chloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-372-10	EA - Each	65162-372	04f562c0-279e-4065-a6a7-ffa4f4d4f338	1	2015-12-02
65162-372-50	EA - Each	65162-372	7fe6aba0-36e2-4630-b646-ba7aef718ece	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-372	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	19	Current NDC, Legacy NDC, 4 package rows	20241031_53924eba-1919-4203-9a1e-d57dfdd3b963.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7688cce8-797d-454c-95fb-52689741582e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204010 application number: ANDA204010
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Amneal Pharmaceuticals LLC	53924eba-1919-4203-9a1e-d57dfdd3b963	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204010 application number: ANDA204010 ndc (product): 65162-372

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	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863628	oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet	PSN	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863636	oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet	PSN	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863619	24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet	SCD	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863628	24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet	SCD	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863636	24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet	SCD	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863619	oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet	SY	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863628	oxybutynin chloride 15 MG 24 HR Extended Release Oral Tablet	SY	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863636	oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet	SY	53924eba-1919-4203-9a1e-d57dfdd3b963	19
863619	oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet	PSN	e7c7c1b4-a5c8-40cc-832c-76d79904b8ef	6
863619	24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet	SCD	e7c7c1b4-a5c8-40cc-832c-76d79904b8ef	6
863619	oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet	SY	e7c7c1b4-a5c8-40cc-832c-76d79904b8ef	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-372-03	65162037203	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-03)	2015-11-02	0000-00-00	No	No	Current
65162-372-09	65162037209	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-09)	2015-11-02	0000-00-00	No	No	Current
65162-372-10	65162037210	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-10)	2015-11-02	0000-00-00	No	No	Current
65162-372-50	65162037250	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-50)	2015-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2023-02-02	HUMAN PRESCRIPTION DRUG LABEL	19
Oxybutynin Chloride	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	6