TRAMADOL HYDROCHLORIDE
- Product NDC
- 76519-1142
- 11-digit product format
- 765191142
- Labeler code
- 76519
- Product ID
- 76519-1142_73e6ec2d-2520-fe20-e053-2991aa0aa037
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2016-07-15
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76519-1142-3 | TRAMADOL HYDROCHLORIDEER | 30 in 1 VIAL, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 76519-1142-6 | TRAMADOL HYDROCHLORIDEER | 60 in 1 VIAL, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1142 | TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 2 package rows | 20180821_7395c20e-2c85-eb95-e053-2991aa0ab760.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1142-3 | 76519114203 | 30 in 1 VIAL, PLASTIC | Historical |
| 76519-1142-6 | 76519114206 | 60 in 1 VIAL, PLASTIC | Historical |