TRAMADOL HYDROCHLORIDE
- Product NDC
- 61919-892
- 11-digit product format
- 619190892
- Labeler code
- 61919
- Product ID
- 61919-892_e9ab11b1-6c36-84f7-e053-2995a90aeb1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- 2023-12-31
- 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 |
|---|
| 61919-892-30 | TRAMADOL HYDROCHLORIDEER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 7 |
| 61919-892-60 | TRAMADOL HYDROCHLORIDEER | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-892 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] | 7 | Legacy NDC, 2 package rows | 20230608_c34a95e3-d508-428f-9022-19cc5a90b4ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-892-30 | 61919089230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-892-30) | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-892-60 | 61919089260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-892-60) | 2022-09-27 | 0000-00-00 | No | No | Current |