TRAMADOL HYDROCHLORIDE
- Product NDC
- 69543-136
- 11-digit product format
- 695430136
- Labeler code
- 69543
- Product ID
- 69543-136_1065b54d-328a-491b-aa20-eaddebd0c119
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Virtus Pharmaceuticals LLC
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- Marketing end
- 2023-06-21
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 43d017e1-6ae6-7555-71d1-c249236d6f26 | Product name | 4 | 20251117 |
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| c563c906-2606-457c-bb1b-5a623daed55b | Product name | 1 | 20210511 |
| 43a9f8f9-34aa-8ae8-719e-5489454f7720 | Product name | 5 | 20200123 |
| abd2f6f2-3fa7-4571-af8a-d67f89bdcb75 | Product name | 1 | 20190927 |
| 377068df-225f-7318-a910-a1987cdfa361 | Product name | 3 | 20170608 |
| 9457302e-0ca3-d9ff-0863-1b24b6107218 | Product name | 1 | 20140508 |
| d5c49867-1fe9-7a44-3319-814417011d51 | Product name | 1 | 20140508 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 8fbcb289-57fd-42ba-a146-25ea55a80a08 | 8 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 8fbcb289-57fd-42ba-a146-25ea55a80a08 | 8 |
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 5f4105f7-be41-4863-8245-f39594672c65 | 3 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 5f4105f7-be41-4863-8245-f39594672c65 | 3 |
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | de66ea8a-f320-483d-a429-724c9b65994e | 2 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | de66ea8a-f320-483d-a429-724c9b65994e | 2 |
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 333b1122-b960-4e20-a675-e2c08361defc | 1 |
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 502297e7-8ecd-3315-e054-00144ff8d46c | 1 |
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 934f43f0-d8f3-aa13-e053-2995a90a7006 | 1 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 333b1122-b960-4e20-a675-e2c08361defc | 1 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 502297e7-8ecd-3315-e054-00144ff8d46c | 1 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 934f43f0-d8f3-aa13-e053-2995a90a7006 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69543-136-10 | 69543013610 | 100 TABLET, FILM COATED in 1 BOTTLE (69543-136-10) | 2015-05-22 | 2023-01-31 | No | No | Current |
| 69543-136-11 | 69543013611 | 1000 TABLET, FILM COATED in 1 BOTTLE (69543-136-11) | 2015-05-22 | 2023-06-21 | No | No | Current |
| 69543-136-50 | 69543013650 | 500 TABLET, FILM COATED in 1 BOTTLE (69543-136-50) | 2015-05-22 | 2023-04-30 | No | No | Current |