Tlando
- Product NDC
- 74676-0112
- 11-digit product format
- 746760112
- Labeler code
- 74676
- Product ID
- 74676-0112_2bcfa6a9-635f-6bc9-ec72-839cca27541e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone undecanoate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Verity Pharmaceuticals Inc.
- Application
- NDA208088
- Marketing category
- NDA
- Marketing start
- 2022-04-15
- Substance
- TESTOSTERONE UNDECANOATE
- Active strength
- 112.5 mg/1
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tlando
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE UNDECANOATE | 112.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H16A5VCT9C |
| Rxcui | 2599054, 2599060 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 74676-0112-2 | Tlando | 120 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 74676-0112 | TLANDOTEE-LAN-DOH (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [VERITY PHARMACEUTICALS INC.] | 3 | Current NDC, 1 package rows | 20240224_4b0b92e9-6d3c-a0e5-e1c7-342999f72580.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 74676-0112-2 | 74676011202 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2) | 2022-04-15 | No | No | Historical |