Tramadol Hydrochloride
- Product NDC
- 53217-960
- 11-digit product format
- 532170960
- Labeler code
- 53217
- Product ID
- 53217-960_b0a7bb34-1716-4902-a5cd-6afaf7b41f54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- NDA022370
- Marketing category
- NDA
- Marketing start
- 2015-07-01
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-960-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 1 |
| 53217-960-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-960 | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20170302_4a135ba1-56b4-487a-bff1-74a850148cc8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-960-30 | 53217096030 | 30 in 1 BOTTLE | Historical |
| 53217-960-60 | 53217096060 | 60 in 1 BOTTLE | Historical |