TRAMADOL HYDROCHLORIDE
- Product NDC
- 76420-246
- 11-digit product format
- 764200246
- Labeler code
- 76420
- Product ID
- 76420-246_e49bb4f0-8b07-c774-e053-2a95a90acff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2011-12-12
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 300 mg/1
- 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
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76420-246-30 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76420-246-30 | EA - Each | 76420-246 | 68244671-eeba-4c27-99a5-ef53450f7824 | 1 | 2022-09-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833709 | traMADol HCl 100 MG 24HR Extended Release Oral Tablet | PSN | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833711 | traMADol HCl 200 MG 24HR Extended Release Oral Tablet | PSN | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833713 | traMADol HCl 300 MG 24HR Extended Release Oral Tablet | PSN | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833709 | 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet | SCD | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833711 | 24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet | SCD | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833713 | 24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet | SCD | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833711 | tramadol HCl 200 MG 24 HR Extended Release Oral Tablet | SY | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833709 | tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet | SY | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
| 833713 | tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet | SY | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76420-246-30 | 76420024630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-246-30) | 2022-07-25 | 0000-00-00 | No | No | Current |