Tramadol Hydrochloride
- Product NDC
- 72888-163
- 11-digit product format
- 728880163
- Labeler code
- 72888
- Product ID
- 72888-163_47c74a4e-51f2-e294-e063-6394a90aa70b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advagen Pharma Limited
- Application
- ANDA208708
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603, 2179635, 2670390, 2692878 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-163-00 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 14 |
| 72888-163-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 14 |
| 72888-163-05 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 14 |
| 72888-163-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-163 | TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVAGEN PHARMA LIMITED] | 12 | Current NDC, 4 package rows | 20240907_93b12089-3a0f-4b57-abb1-2429cf31995d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-163-00 | 72888016300 | 1000 TABLET, COATED in 1 BOTTLE (72888-163-00) | 2023-07-24 | No | No | Current |
| 72888-163-01 | 72888016301 | 100 TABLET, COATED in 1 BOTTLE (72888-163-01) | 2023-07-24 | No | No | Current |
| 72888-163-05 | 72888016305 | 500 TABLET, COATED in 1 BOTTLE (72888-163-05) | 2023-07-24 | No | No | Current |
| 72888-163-30 | 72888016330 | 30 TABLET, COATED in 1 BOTTLE (72888-163-30) | 2023-07-24 | No | No | Current |