Tramadol Hydrochloride
- Product NDC
- 0378-4153
- 11-digit product format
- 003784153
- Labeler code
- 0378
- Product ID
- 0378-4153_fa56c2ff-b0f4-4356-ba0b-4246ad19e521
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205257
- Marketing category
- ANDA
- Marketing start
- 2016-03-16
- Marketing end
- 2022-04-30
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4153-93 | 00378415393 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4153-93) | 2016-03-16 | 0000-00-00 | No | No | Current |