Tramadol Hydrochloride
- Product NDC
- 82804-142
- 11-digit product format
- 828040142
- Labeler code
- 82804
- Product ID
- 82804-142_e878d5e0-2cab-4e0a-9a85-22b34420dcf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208708
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-142-15 | Tramadol Hydrochloride | 15 in 1 BOTTLE | TABLET, COATED | 15 | | 4 |
| 82804-142-20 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET, COATED | 20 | | 4 |
| 82804-142-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 4 |
| 82804-142-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 4 |
| 82804-142-72 | Tramadol Hydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 4 |
| 82804-142-78 | Tramadol Hydrochloride | 180 in 1 BOTTLE | TABLET, COATED | 180 | | 4 |
| 82804-142-90 | Tramadol Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-142 | TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP] | 4 | Current NDC, 7 package rows | 20250119_d7e75fd3-18d1-4370-bb63-c9dd8a2c1719.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-142-15 | 82804014215 | 15 TABLET, COATED in 1 BOTTLE (82804-142-15) | 2024-10-21 | No | No | Current |
| 82804-142-20 | 82804014220 | 20 TABLET, COATED in 1 BOTTLE (82804-142-20) | 2024-09-19 | No | No | Current |
| 82804-142-30 | 82804014230 | 30 TABLET, COATED in 1 BOTTLE (82804-142-30) | 2024-09-19 | No | No | Current |
| 82804-142-60 | 82804014260 | 60 TABLET, COATED in 1 BOTTLE (82804-142-60) | 2024-09-19 | No | No | Current |
| 82804-142-72 | 82804014272 | 120 TABLET, COATED in 1 BOTTLE (82804-142-72) | 2024-11-05 | No | No | Current |
| 82804-142-78 | 82804014278 | 180 TABLET, COATED in 1 BOTTLE (82804-142-78) | 2025-01-15 | No | No | Current |
| 82804-142-90 | 82804014290 | 90 TABLET, COATED in 1 BOTTLE (82804-142-90) | 2024-09-19 | No | No | Current |