TRAMADOL HYDROCHLORIDE
- Product NDC
- 63187-597
- 11-digit product format
- 631870597
- Labeler code
- 63187
- Product ID
- 63187-597_9cd8b7ee-83bb-46fd-b5a2-2a38e55c577f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2011-12-12
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRAMADOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 833709 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-597-30 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 63187-597-60 | TRAMADOL HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 4 |
| 63187-597-90 | TRAMADOL HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-597 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20220513_27495d02-8641-4c92-b5a3-edf50abc2a6f.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 |
|---|
| 63187-597-30 | 63187059730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-597-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-597-60 | 63187059760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-597-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-597-90 | 63187059790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-597-90) | 2018-12-01 | 0000-00-00 | No | No | Current |