Molindone Hydrochloride
- Product NDC
- 42806-337
- 11-digit product format
- 428060337
- Labeler code
- 42806
- Product ID
- 42806-337_d7c8ea49-c06c-441d-820e-def3920f7c1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Molindone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA090453
- Marketing category
- ANDA
- Marketing start
- 2018-10-17
- Substance
- MOLINDONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Molindone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOLINDONE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1DWS68PNE6 |
| Rxcui | 1298816, 1298906, 1298910 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-337-01 | Molindone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-337 | MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231221_1275e92f-9573-4d0c-8e77-1c9ac47696d2.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 |
|---|
| 42806-337-01 | 42806033701 | 100 TABLET in 1 BOTTLE (42806-337-01) | 100 tablet | 2018-10-17 | 0000-00-00 | No | No | Current |