Home NDC 0603-4975-28 Oxybutynin Chloride
Product NDC 0603-4975
Requested package NDC 0603-4975-28
11-digit product format 006034975
Labeler code 0603
Product ID 0603-4975_7be4f3e4-9b24-4ada-910d-2901985af9b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxybutynin chloride
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA075079
Marketing category ANDA
Marketing start 1997-10-31
Marketing end 2023-12-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 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 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
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 · 44 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 2026-08-18 06:07:40 2026-07 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075079-002 OXYBUTYNIN CHLORIDE 2.5MG TABLET / ORAL AB 2026-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 79d66fd596c7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [QUALITEST PHARMACEUTICALS] 12 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 4 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 2 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0603-4975-28 00603497528 500 TABLET in 1 BOTTLE, PLASTIC (0603-4975-28) 500 tablet 1997-10-31 2023-12-31 No No Current