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
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| OXYBUTYNIN | ACTIVE MOIETY | K9P6MC7092 | OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS 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 | |
| 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 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 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 [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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 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 | |
| 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 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYBUTYNIN CHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYBUTYNIN CHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 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 |