Oxybutynin Chloride

Product NDC: 0615-8428
Requested package NDC: 0615-8428-39
11-digit product format: 006158428
Labeler code: 0615
Product ID: 0615-8428_06081cba-ac29-4db7-9504-463425b03ae0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxybutynin chloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA075079
Marketing category: ANDA
Marketing start: 2022-04-04
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0615-8428	0615-8428-39	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075079-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31
A075079-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075079-001	AB
A075079-002	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	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075079-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A075079-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075079-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Strides Pharma Science Limited	9ede5def-d185-4e40-9c10-8663ac654caf	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2425f49f-ade3-5178-e063-6294a90adfac	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079

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
0615-8428-39	00615842839	30 TABLET in 1 BLISTER PACK (0615-8428-39)	30 tablet	2022-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP	NCS HealthCare of KY, LLC dba Vangard Labs \| Strides Pharma, Inc	2023-08-08	HUMAN PRESCRIPTION DRUG LABEL	5