Tramadol Hydrochloride
- Product NDC
- 53002-4320
- 11-digit product format
- 530024320
- Labeler code
- 53002
- Product ID
- 53002-4320_db15f0d7-7052-4549-bab3-dcf19b0b7164
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2010-11-15
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-4320-1 | Tramadol Hydrochloride | 10 in 1 BOTTLE | TABLET, COATED | 10 | 5 | |
| 53002-4320-2 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET, COATED | 20 | 5 | |
| 53002-4320-3 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-4320 | TRAMADOL HYDROCHLORIDE TABLET, COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_1279bffe-3494-4016-803c-abbf8fd8f023.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 835603 | traMADol HCl 50 MG Oral Tablet | PSN | 1279bffe-3494-4016-803c-abbf8fd8f023 | 5 |
| 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD | 1279bffe-3494-4016-803c-abbf8fd8f023 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53002-4320-1 | 53002432001 | 10 TABLET, COATED in 1 BOTTLE (53002-4320-1) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-4320-2 | 53002432002 | 20 TABLET, COATED in 1 BOTTLE (53002-4320-2) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-4320-3 | 53002432003 | 30 TABLET, COATED in 1 BOTTLE (53002-4320-3) | 2017-10-01 | 0000-00-00 | No | No | Current |