Tramadol Hydrochloride
- Product NDC
- 60219-2348
- 11-digit product format
- 602192348
- Labeler code
- 60219
- Product ID
- 60219-2348_12ec39ff-7a96-4467-a778-7537868c0ccd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2023-02-13
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 60219-2348-1 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 4 |
| 60219-2348-4 | Tramadol Hydrochloride | 10 in 1 BOTTLE | TABLET, COATED | 10 | | 4 |
| 60219-2348-5 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 4 |
| 60219-2348-7 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-2348 | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS NY LLC] | 2 | Current NDC, 4 package rows | 20241127_8ec4e4e5-a56e-4198-8428-6b770b9bf27d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-2348-1 | 60219234801 | 100 TABLET, COATED in 1 BOTTLE (60219-2348-1) | 2023-02-13 | No | No | Current |
| 60219-2348-4 | 60219234804 | 10 TABLET, COATED in 1 BOTTLE (60219-2348-4) | 2023-02-13 | No | No | Current |
| 60219-2348-5 | 60219234805 | 500 TABLET, COATED in 1 BOTTLE (60219-2348-5) | 2023-02-13 | No | No | Current |
| 60219-2348-7 | 60219234807 | 1000 TABLET, COATED in 1 BOTTLE (60219-2348-7) | 2023-02-13 | No | No | Current |