Oxybutynin Chloride

Product NDC: 67046-1381
Requested package NDC: 67046-1381-3
11-digit product format: 670461381
Labeler code: 67046
Product ID: 67046-1381_55f616e5-fc5a-5790-e063-6294a90aeeb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA208165
Marketing category: ANDA
Marketing start: 2026-07-06
Marketing end: 2027-08-31
Substance: OXYBUTYNIN CHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208165-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2020-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208165-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208165-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208165-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208165-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208165-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208165-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208165-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208165-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208165-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208165-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208165-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208165-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208165-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208165-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208165-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208165-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208165-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208165-001	AB	1	`8072bd15b7f6…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208165-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208165-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208165-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208165-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208165-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208165-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208165-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208165-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208165-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208165-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208165-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208165-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208165-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208165-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208165-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Oxybutynin Chloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN CHLORIDE	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863664	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
55f618d1-4463-3200-e063-6394a90a89a8	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Coupler LLC	55f618d1-4463-3200-e063-6394a90a89a8	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165 ndc (package): 67046-1381-3 ndc (product): 67046-1381 ndc11 (package): 67046138103
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Strides Pharma Science Limited	ac10c7b7-d0cb-4068-93e2-c0e51f15866e	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	American Health Packaging	4574b227-9726-4798-bac2-83bfb9616f09	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9a551ec5-7e80-47c9-a7b9-f458c1478174	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	AvKARE	3418ca19-feb0-9821-e063-6394a90ae819	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-1381-3	67046138103	30 TABLET in 1 BLISTER PACK (67046-1381-3)	30 tablet	2026-07-06	2027-08-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS, USP	Coupler LLC \| Strides Pharma Global Pte. Ltd.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	1