Tramadol Hydrochloride
- Product NDC
- 68788-8121
- 11-digit product format
- 687888121
- Labeler code
- 68788
- Product ID
- 68788-8121_df7262b6-db63-49dc-8f70-c8998210d8ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA208708
- Marketing category
- ANDA
- Marketing start
- 2022-01-05
- 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 |
|---|
| 68788-8121-1 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 4 |
| 68788-8121-2 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET, COATED | 20 | | 4 |
| 68788-8121-3 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 4 |
| 68788-8121-4 | Tramadol Hydrochloride | 40 in 1 BOTTLE | TABLET, COATED | 40 | | 4 |
| 68788-8121-5 | Tramadol Hydrochloride | 15 in 1 BOTTLE | TABLET, COATED | 15 | | 4 |
| 68788-8121-6 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 4 |
| 68788-8121-7 | Tramadol Hydrochloride | 50 in 1 BOTTLE | TABLET, COATED | 50 | | 4 |
| 68788-8121-8 | Tramadol Hydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 4 |
| 68788-8121-9 | 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 |
|---|
| 68788-8121 | TRAMADOL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 9 package rows | 20240822_84b12129-cf10-4a3e-889c-990ebabdece6.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 |
|---|
| 68788-8121-1 | 68788812101 | 100 TABLET, COATED in 1 BOTTLE (68788-8121-1) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-2 | 68788812102 | 20 TABLET, COATED in 1 BOTTLE (68788-8121-2) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-3 | 68788812103 | 30 TABLET, COATED in 1 BOTTLE (68788-8121-3) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-4 | 68788812104 | 40 TABLET, COATED in 1 BOTTLE (68788-8121-4) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-5 | 68788812105 | 15 TABLET, COATED in 1 BOTTLE (68788-8121-5) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-6 | 68788812106 | 60 TABLET, COATED in 1 BOTTLE (68788-8121-6) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-7 | 68788812107 | 50 TABLET, COATED in 1 BOTTLE (68788-8121-7) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-8 | 68788812108 | 120 TABLET, COATED in 1 BOTTLE (68788-8121-8) | 2022-01-05 | 0000-00-00 | No | No | Current |
| 68788-8121-9 | 68788812109 | 90 TABLET, COATED in 1 BOTTLE (68788-8121-9) | 2022-01-05 | 0000-00-00 | No | No | Current |