Bicalutamide
- Product NDC
- 16714-816
- 11-digit product format
- 167140816
- Labeler code
- 16714
- Product ID
- 16714-816_96d5cdb2-e538-fecd-e053-2995a90aace4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar RxLLC
- Application
- ANDA078917
- Marketing category
- ANDA
- Marketing start
- 2018-06-01
- Marketing end
- 0000-00-00
- Substance
- BICALUTAMIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-816 | BICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC] | 3 | Legacy NDC | 20240718_ad46d58b-3f81-4bcf-bf5f-de70c8b6c930.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-816-01 | 16714081601 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01) | 2018-06-01 | 0000-00-00 | No | No | Current |
| 16714-816-02 | 16714081602 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-816-02) | 2018-06-01 | 0000-00-00 | No | No | Current |