Oxybutynin Chloride

Product NDC: 63629-1354
Requested package NDC: 63629-1354-4
11-digit product format: 636291354
Labeler code: 63629
Product ID: 63629-1354_6f66dcc8-7f59-4203-9068-2be0f0544b46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxybutynin chloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075079
Marketing category: ANDA
Marketing start: 1997-10-31
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: 2020-12-31
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	63629-1354	63629-1354-4	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
2022-11-12 20:34 UTC	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
2022-11-12 20:34 UTC	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1354-1	EA - Each	63629-1354	c3e78537-61ed-47ad-8903-f103b9a58545	1	2012-07-24
63629-1354-2	EA - Each	63629-1354	55674890-3dde-46e1-8192-33783844a2f3	1	2012-07-24
63629-1354-3	EA - Each	63629-1354	f602099d-5d74-4ea3-84a2-504509cbb639	1	2012-07-24
63629-1354-4	EA - Each	63629-1354	e7bf96b1-5a93-49ef-acb5-ed72161fda7f	1	2012-07-24
63629-1354-5	EA - Each	63629-1354	93bfaf1d-7e7a-433f-9503-21ca4bf4b8b7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	2

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
63629-1354-4	63629135404	60 TABLET in 1 BOTTLE, PLASTIC (63629-1354-4)	60 tablet	1997-10-31	0000-00-00	No	No	Current