Dutasteride
- Product NDC
- 53345-037
- 11-digit product format
- 533450037
- Labeler code
- 53345
- Product ID
- 53345-037_b5d3028b-d3d8-40b8-b013-9a7e99c3eaef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- ANDA209909
- Marketing category
- ANDA
- Marketing start
- 2018-04-25
- Marketing end
- 0000-00-00
- Substance
- DUTASTERIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-037-01 | Dutasteride | 12000 in 1 BAG | CAPSULE, LIQUID FILLED | 12000 | | 1 |
| 53345-037-01 | Dutasteride | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-037 | DUTASTERIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | Legacy NDC, 2 package rows | 20180426_cf1cbcbf-f466-4caf-9ba1-2faccdc2a3cf.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 |
|---|
| 53345-037-01 | 53345003701 | 1 BAG in 1 BOX (53345-037-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2018-04-25 | 0000-00-00 | No | No | Current |