Tadalafil
- Product NDC
- 69097-375
- 11-digit product format
- 690970375
- Labeler code
- 69097
- Product ID
- 69097-375_92ec5f3d-f54d-4f28-bac6-b606c99b17c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA209539
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- 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 |
|---|
| 69097-375 | TADALAFIL TABLET, FILM COATED [CIPLA USA INC.] | 7 | Legacy NDC | 20221226_07fc5cfc-86c9-46b9-ad5a-8d8638a3fc42.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-375-02 | 69097037502 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-375-02) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 69097-375-05 | 69097037505 | 90 TABLET, FILM COATED in 1 BOTTLE (69097-375-05) | 2019-03-26 | 0000-00-00 | No | No | Current |
| 69097-375-15 | 69097037515 | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-375-15) | 2019-03-26 | 0000-00-00 | No | No | Current |