Tramadol Hydrochloride
- Product NDC
- 52605-010
- 11-digit product format
- 526050010
- Labeler code
- 52605
- Product ID
- 52605-010_79c1086e-6517-4053-87e6-ebfe9e413da6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- POLYGEN PHARMACEUTICALS INC.
- Application
- ANDA206706
- Marketing category
- ANDA
- Marketing start
- 2020-06-01
- 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
- 2020-12-31
- 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 |
|---|
| 52605-010-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 52605-010-10 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-010 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [POLYGEN PHARMACEUTICALS INC.] | 7 | Legacy NDC, 2 package rows | 20200601_3606bf61-ad10-49b5-af85-27c7a8c06e70.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52605-010-01 | 52605001001 | 100 in 1 BOTTLE | Historical |
| 52605-010-10 | 52605001010 | 1000 in 1 BOTTLE | Historical |