Home NDC 50111-456-99 Oxybutynin Chloride
Product NDC 50111-456
Requested package NDC 50111-456-99
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 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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071655-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071655-001 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.
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50111-456-01 Oxybutynin Chloride 100 in 1 BOTTLE TABLET 100 15 50111-456-02 Oxybutynin Chloride 500 in 1 BOTTLE TABLET 500 15 50111-456-03 Oxybutynin Chloride 1000 in 1 BOTTLE TABLET 1000 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.] 7 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50111-456 OXYBUTYNIN CHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20241127_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 50111-456-99 50111045699 55586 TABLET in 1 CONTAINER (50111-456-99) 55586 tablet 23-SEP-19 Current