Tramadol Hydrochloride
- Product NDC
- 16571-716
- 11-digit product format
- 165710716
- Labeler code
- 16571
- Product ID
- 16571-716_0803af00-9ccd-46e7-b1f6-571ce6674049
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA203494
- Marketing category
- ANDA
- Marketing start
- 2020-09-23
- 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 |
|---|
| 16571-716-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 16571-716-10 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
| 16571-716-50 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-716 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240316_a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3.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 |
|---|
| 16571-716-01 | 16571071601 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-716-01) | 2020-09-23 | 0000-00-00 | No | No | Current |
| 16571-716-10 | 16571071610 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-716-10) | 2020-09-23 | 0000-00-00 | No | No | Current |
| 16571-716-50 | 16571071650 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-716-50) | 2020-09-23 | 0000-00-00 | No | No | Current |