TRAMADOL HYDROCHLORIDE
- Product NDC
- 68788-7601
- 11-digit product format
- 687887601
- Labeler code
- 68788
- Product ID
- 68788-7601_002cc3ab-993f-4e80-a885-c07bfd4b5dc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2020-02-06
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 833711 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7601-2 | TRAMADOL HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | | 7 |
| 68788-7601-3 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 7 |
| 68788-7601-6 | TRAMADOL HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 7 |
| 68788-7601-9 | TRAMADOL HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7601 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240822_83367367-5654-4078-831a-69ade48bc795.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 |
|---|
| 68788-7601-2 | 68788760102 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-2) | 2020-02-06 | 0000-00-00 | No | No | Current |
| 68788-7601-3 | 68788760103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-3) | 2020-02-06 | 0000-00-00 | No | No | Current |
| 68788-7601-6 | 68788760106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-6) | 2020-02-06 | 0000-00-00 | No | No | Current |
| 68788-7601-9 | 68788760109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-9) | 2020-02-06 | 0000-00-00 | No | No | Current |