TRAMADOL HYDROCHLORIDE
- Product NDC
- 71610-398
- 11-digit product format
- 716100398
- Labeler code
- 71610
- Product ID
- 71610-398_1dff6bc2-aaf7-4003-a970-d18125b491fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 71610-398 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20200330_9c627ec3-d1fb-4d60-9adb-6a5be26f0bba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-398-15 | 71610039815 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-398-15) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-20 | 71610039820 | 20 TABLET, FILM COATED in 1 BOTTLE (71610-398-20) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-24 | 71610039824 | 224 TABLET, FILM COATED in 1 BOTTLE (71610-398-24) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-28 | 71610039828 | 28 TABLET, FILM COATED in 1 BOTTLE (71610-398-28) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-30 | 71610039830 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-398-30) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-40 | 71610039840 | 40 TABLET, FILM COATED in 1 BOTTLE (71610-398-40) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-45 | 71610039845 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-398-45) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-46 | 71610039846 | 56 TABLET, FILM COATED in 1 BOTTLE (71610-398-46) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-50 | 71610039850 | 50 TABLET, FILM COATED in 1 BOTTLE (71610-398-50) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-53 | 71610039853 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-398-53) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-54 | 71610039854 | 84 TABLET, FILM COATED in 1 BOTTLE (71610-398-54) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-57 | 71610039857 | 80 TABLET, FILM COATED in 1 BOTTLE (71610-398-57) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-60 | 71610039860 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-398-60) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-65 | 71610039865 | 100 TABLET, FILM COATED in 1 BOTTLE (71610-398-65) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-67 | 71610039867 | 168 TABLET, FILM COATED in 1 BOTTLE (71610-398-67) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-70 | 71610039870 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-398-70) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-72 | 71610039872 | 112 TABLET, FILM COATED in 1 BOTTLE (71610-398-72) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-73 | 71610039873 | 135 TABLET, FILM COATED in 1 BOTTLE (71610-398-73) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-75 | 71610039875 | 150 TABLET, FILM COATED in 1 BOTTLE (71610-398-75) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-80 | 71610039880 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-398-80) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-85 | 71610039885 | 200 TABLET, FILM COATED in 1 BOTTLE (71610-398-85) | 2020-02-21 | 0000-00-00 | No | No | Current |
| 71610-398-90 | 71610039890 | 240 TABLET, FILM COATED in 1 BOTTLE (71610-398-90) | 2020-02-21 | 0000-00-00 | No | No | Current |