Home NDC 0603-4975 Oxybutynin Chloride
Product NDC 0603-4975
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 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.
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 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 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.
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
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 0603-4975-21 00603497521 100 TABLET in 1 BOTTLE, PLASTIC (0603-4975-21) 100 tablet 1997-10-31 0000-00-00 No No Current 0603-4975-28 00603497528 500 TABLET in 1 BOTTLE, PLASTIC (0603-4975-28) 500 tablet 1997-10-31 0000-00-00 No No Current 0603-4975-32 00603497532 1000 TABLET in 1 BOTTLE, PLASTIC (0603-4975-32) 1000 tablet 1997-10-31 0000-00-00 No No Current