Flavoxate Hydrochloride
- Product NDC
- 42806-058
- 11-digit product format
- 428060058
- Labeler code
- 42806
- Product ID
- 42806-058_6aeb8856-3df7-40a7-b03e-d855a58c8fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flavoxate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA076835
- Marketing category
- ANDA
- Marketing start
- 2011-02-21
- Substance
- FLAVOXATE HYDROCHLORIDE
- Active strength
- 100 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flavoxate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLAVOXATE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9C05J6089W |
| Rxcui | 1095229 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-058-01 | Flavoxate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 42806-058-10 | Flavoxate Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLAVOXATE HYDROCHLORIDE | ACTIVE INGREDIENT | 9C05J6089W | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| FLAVOXATE | ACTIVE MOIETY | 3E74Y80MEY | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-058 | FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20231228_b4260d7e-2ab3-49f6-aa57-bae19a23d82a.zip |
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 |
|---|
| 42806-058-01 | 42806005801 | 100 TABLET in 1 BOTTLE (42806-058-01) | 100 tablet | 2011-02-21 | 0000-00-00 | No | No | Current |
| 42806-058-10 | 42806005810 | 1000 TABLET in 1 BOTTLE (42806-058-10) | 1000 tablet | 2011-02-21 | 0000-00-00 | No | No | Current |