Tlando
- Product NDC
- 54436-112
- 11-digit product format
- 544360112
- Labeler code
- 54436
- Product ID
- 54436-112_dcd3d0e0-089f-430c-9f1a-1bbbea82e737
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone undecanoate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Antares Pharma, Inc.
- Application
- NDA208088
- Marketing category
- NDA
- Marketing start
- 2022-04-15
- Marketing end
- 0000-00-00
- Substance
- TESTOSTERONE UNDECANOATE
- Active strength
- 113 mg/1
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 54436-112 | TLANDO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [ANTARES PHARMA, INC.] | 4 | Legacy NDC | 20250202_479b55bd-2023-486a-8922-3b1de48b935c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54436-112-20 | 54436011220 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20) | 2022-04-15 | 0000-00-00 | No | No | Current |