Oxybutynin Chloride

Product NDC: 62135-520
11-digit product format: 621350520
Labeler code: 62135
Product ID: 62135-520_2f102c1a-f5e5-43a2-e063-6294a90a0a91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA075039
Marketing category: ANDA
Marketing start: 1999-01-29
Substance: OXYBUTYNIN CHLORIDE
Active strength: 5 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075039-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA		1999-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075039-001	AA

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 2 · 41 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	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL	AA	1999-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075039-001	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP / ORAL		1999-01-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075039-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075039-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075039-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075039-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075039-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075039-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075039-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075039-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075039-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075039-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075039-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075039-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075039-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075039-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075039-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075039-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075039-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075039-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075039-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075039-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075039-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075039-001	AA	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075039-001	AA	1	`a50c72e98297…`

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	5 mg/5mL

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
863599	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
d02e411b-2f34-4d08-a92a-9762cab47269	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
62135-520-05	Oxybutynin Chloride	5 mL in 1 CUP	SOLUTION	5	2
62135-520-24	Oxybutynin Chloride	2 in 1 BOX	SOLUTION	2	2
62135-520-24	Oxybutynin Chloride	10 in 1 TRAY	SOLUTION	10	2
62135-520-47	Oxybutynin Chloride	473 mL in 1 BOTTLE	SOLUTION	473	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-520-05	ML - Milliliter	62135-520	e2171b21-8cc7-42cc-b3b1-91b7e0a7f954	1	2025-05-14
62135-520-24	ML - Milliliter	62135-520	5df0034f-a3cc-4d28-9435-ae14c1181857	1	2025-05-14
62135-520-47	ML - Milliliter	62135-520	e8f5f306-8d83-45c2-b683-a4d520825ca2	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-520	OXYBUTYNIN CHLORIDE SOLUTION [CHARTWELL RX, LLC]	2	Current NDC, Legacy NDC, 4 package rows	20250228_d02e411b-2f34-4d08-a92a-9762cab47269.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	Chartwell Governmental & Specialty RX, LLC.	46e78c72-a5a3-472f-9125-b120fa4eee31	2026-01-30	Adverse reactions	Exact identifier application applno (ANDA): 075039 application number: ANDA075039
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Chartwell RX, LLC	d02e411b-2f34-4d08-a92a-9762cab47269	2025-02-26	Adverse reactions	Exact identifier application applno (ANDA): 075039 application number: ANDA075039 ndc (product): 62135-520

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
863599	oxyBUTYnin chloride 5 MG in 5 mL Oral Solution	PSN	d02e411b-2f34-4d08-a92a-9762cab47269	2
863599	oxybutynin chloride 1 MG/ML Oral Solution	SCD	d02e411b-2f34-4d08-a92a-9762cab47269	2
863599	oxybutynin chloride 5 MG per 5 ML Oral Solution	SY	d02e411b-2f34-4d08-a92a-9762cab47269	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-520-05	62135052005	5 mL in 1 CUP	5 ml					Historical
62135-520-24	62135052024	2 TRAY in 1 BOX (62135-520-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-520-05)	2 tray	2025-02-26		No	No	Current
62135-520-47	62135052047	473 mL in 1 BOTTLE (62135-520-47)	473 ml	2022-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Oral Solution, USP	Chartwell RX, LLC	2025-02-26	HUMAN PRESCRIPTION DRUG LABEL	2