Tramadol Hydrochloride
- Product NDC
- 52817-615
- 11-digit product format
- 528170615
- Labeler code
- 52817
- Product ID
- 52817-615_f7fd27bd-cd40-704c-e053-6394a90a6a6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- TruPharma, LLC
- Application
- NDA214044
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-09-11
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 2395808 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-615-16 | Tramadol Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-615 | TRAMADOL HYDROCHLORIDE SOLUTION [TRUPHARMA, LLC] | 1 | Current NDC, 1 package rows | 20230329_aea56ff9-94ac-47a8-8f15-8790d538973b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52817-615-16 | 52817061516 | 473 mL in 1 BOTTLE (52817-615-16) | 473 ml | 2023-01-25 | No | No | Current |