Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 53217-040
- 11-digit product format
- 532170040
- Labeler code
- 53217
- Product ID
- 53217-040_89d35016-9fee-46c7-8f7d-9168a2ad383a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53217-040-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 53217-040-98 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd28-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-040-00 | Tramadol Hydrochloride and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 53217-040-02 | Tramadol Hydrochloride and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 53217-040-20 | Tramadol Hydrochloride and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
| 53217-040-30 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-040-40 | Tramadol Hydrochloride and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | | 1 |
| 53217-040-60 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-040-90 | Tramadol Hydrochloride and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 53217-040-98 | Tramadol Hydrochloride and Acetaminophen | 168 in 1 BOTTLE | TABLET | 168 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-040 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 8 package rows | 20141029_a1ddeea2-763e-4c37-a9f8-b57906c80a28.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-040-00 | 53217004000 | 100 in 1 BOTTLE | Historical |
| 53217-040-02 | 53217004002 | 120 in 1 BOTTLE | Historical |
| 53217-040-20 | 53217004020 | 20 in 1 BOTTLE | Historical |
| 53217-040-30 | 53217004030 | 30 in 1 BOTTLE | Historical |
| 53217-040-40 | 53217004040 | 40 in 1 BOTTLE | Historical |
| 53217-040-60 | 53217004060 | 60 in 1 BOTTLE | Historical |
| 53217-040-90 | 53217004090 | 90 in 1 BOTTLE | Historical |
| 53217-040-98 | 53217004098 | 168 in 1 BOTTLE | Historical |