Tramadol Hydrochloride
- Product NDC
- 29300-355
- 11-digit product format
- 293000355
- Labeler code
- 29300
- Product ID
- 29300-355_2e474886-5eb1-4fa0-b53e-04281e31b631
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA211825
- Marketing category
- ANDA
- Marketing start
- 2019-08-09
- 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 |
|---|
| 29300-355-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 26 |
| 29300-355-05 | Tramadol Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 26 |
| 29300-355-10 | Tramadol Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-355 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 17 | Current NDC, Legacy NDC, 3 package rows | 20240207_007bf37f-0e46-426a-ac8c-be63d4b7414c.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 |
|---|
| 29300-355-01 | 29300035501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-01) | 2019-11-04 | 0000-00-00 | No | No | Current |
| 29300-355-05 | 29300035505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-05) | 2019-11-04 | 0000-00-00 | No | No | Current |
| 29300-355-10 | 29300035510 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-10) | 2019-11-04 | 0000-00-00 | No | No | Current |