ZIOPTAN
- Product NDC
- 82584-609
- 11-digit product format
- 825840609
- Labeler code
- 82584
- Product ID
- 82584-609_50281dbf-7a22-69dc-e063-6294a90a2cb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tafluprost
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Thea Pharma Inc.
- Application
- NDA202514
- Marketing category
- NDA
- Marketing start
- 2022-10-28
- Substance
- TAFLUPROST
- Active strength
- .015 mg/mL
- Pharmacologic classes
- Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZIOPTAN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TAFLUPROST | .015 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1O6WQ6T7G3 |
| Rxcui | 1244611, 1244616 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82584-609-01 | ZIOPTAN | 0.3 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 0.3 | | 7 |
| 82584-609-01 | ZIOPTAN | 10 in 1 POUCH | SOLUTION/ DROPS | 10 | | 7 |
| 82584-609-30 | ZIOPTAN | 3 in 1 CARTON | SOLUTION/ DROPS | 3 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82584-609 | ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [THEA PHARMA INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240430_db529b54-2ac7-4020-9791-7333bbe6c90f.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 |
|---|
| 82584-609-01 | 82584060901 | 0.3 mL in 1 VIAL, SINGLE-USE | 0.3 ml | | | | | Historical |
| 82584-609-30 | 82584060930 | 3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE | 3 pouch | 2022-10-28 | 0000-00-00 | No | No | Current |