Oxybutynin Chloride

Product NDC
50111-456
11-digit product format
501110456
Labeler code
50111
Product ID
50111-456_1811d8f0-3236-4dc7-a270-49e870188ff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071655
Marketing category
ANDA
Marketing start
1990-09-30
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct50111-456UNFINISHEDActive or certified unfinished drug listing2026-08-07
unfinished packagepackage50111-45650111-456-99UNFINISHEDActive or certified unfinished drug listing2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 40 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage50111-456-99a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage50111-456-991d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage50111-456-99390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage50111-456-99e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage50111-456-99bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage50111-456-99f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage50111-456-99f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage50111-456-9968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage50111-456-9905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage50111-456-9948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage50111-456-9927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage50111-456-998d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage50111-456-99d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage50111-456-9950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage50111-456-99906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage50111-456-996db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage50111-456-998fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage50111-456-994184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage50111-456-994bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage50111-456-99263afe128892…91768de4ddbe…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071655-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071655-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071655-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1988-11-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071655-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071655-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071655-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071655-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071655-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071655-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071655-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071655-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071655-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071655-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071655-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071655-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071655-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071655-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071655-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071655-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071655-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071655-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071655-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071655-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071655-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071655-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071655-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071655-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071655-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071655-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071655-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071655-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071655-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071655-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071655-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071655-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071655-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071655-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071655-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071655-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071655-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071655-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071655-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071655-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L9F3D9RENQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863664Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50111-456-01Oxybutynin Chloride100 in 1 BOTTLETABLET10015
50111-456-02Oxybutynin Chloride500 in 1 BOTTLETABLET50015
50111-456-03Oxybutynin Chloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-456-01EA - Each50111-4564c8ca356-7fd1-4818-8ac7-906b87bca92d12012-07-24
50111-456-02EA - Each50111-4566f3c41c8-421e-4e28-94a8-3cbce353632c12012-07-24
50111-456-03EA - Each50111-4569b6b2ff6-8b9d-4078-ab17-cab3d192975d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-456OXYBUTYNIN CHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20241127_cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEdirect rxb3d6d2a8-97c4-5bad-e053-2a95a90a155d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071655
application number: ANDA071655
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack246d2f79-8ab5-4023-9068-1451b695ac162024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071655
application number: ANDA071655
Oxybutynin ChlorideOXYBUTYNIN CHLORIDETeva Pharmaceuticals USA, Inc.cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a292024-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071655
application number: ANDA071655
ndc (product): 50111-456
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEProficient Rx LPe3f0c249-8085-4979-823a-820e233a284f2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071655
application number: ANDA071655

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNcb7aba8d-6913-4f57-8eb4-c6d6ff0b2a2915
863664oxybutynin chloride 5 MG Oral TabletSCDcb7aba8d-6913-4f57-8eb4-c6d6ff0b2a2915
863664oxyBUTYnin chloride 5 MG Oral TabletPSNe3f0c249-8085-4979-823a-820e233a284f5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN246d2f79-8ab5-4023-9068-1451b695ac165
863664oxybutynin chloride 5 MG Oral TabletSCD246d2f79-8ab5-4023-9068-1451b695ac165
863664oxybutynin chloride 5 MG Oral TabletSCDe3f0c249-8085-4979-823a-820e233a284f5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN19fba9db-69ff-4136-ad6b-04a33b6b67894
863664oxybutynin chloride 5 MG Oral TabletSCD19fba9db-69ff-4136-ad6b-04a33b6b67894
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxyBUTYnin chloride 5 MG Oral TabletPSNb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxybutynin chloride 5 MG Oral TabletSCDb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxyBUTYnin chloride 5 MG Oral TabletPSNd2aa1b90-bea7-4a93-b2e7-22710548ff551
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0fed0008-6569-3728-e054-00144ff88e881
863664oxybutynin chloride 5 MG Oral TabletSCD0fed0008-6569-3728-e054-00144ff88e881
863664oxybutynin chloride 5 MG Oral TabletSCDd2aa1b90-bea7-4a93-b2e7-22710548ff551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-456-0150111045601100 TABLET in 1 BOTTLE (50111-456-01) 100 tablet1990-09-300000-00-00NoNoCurrent
50111-456-0250111045602500 TABLET in 1 BOTTLE (50111-456-02) 500 tablet1990-09-300000-00-00NoNoCurrent
50111-456-03501110456031000 TABLET in 1 BOTTLE (50111-456-03) 1000 tablet1990-09-300000-00-00NoNoCurrent
50111-456-995011104569955586 TABLET in 1 CONTAINER (50111-456-99)55586 tablet23-SEP-19Current