Tramadol Hydrochloride
- Product NDC
- 45865-357
- 11-digit product format
- 458650357
- Labeler code
- 45865
- Product ID
- 45865-357_1b439a3a-319a-43fd-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2014-02-14
- 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
- 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 |
|---|
| 45865-357-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca3f-f424-e053-dadaa90a57ce | TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION |
| 45865-357-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca3f-f424-e053-dadaa90a57ce | TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION |
| 45865-357-51 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca3f-f424-e053-dadaa90a57ce | TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION |
| 45865-357-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca3f-f424-e053-dadaa90a57ce | TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION |
| 45865-357-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca3f-f424-e053-dadaa90a57ce | TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP, FULL PRESCRIBING INFORMATION |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-357-20 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 45865-357-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 45865-357-51 | Tramadol Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
| 45865-357-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 45865-357-90 | Tramadol Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-357 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 4 | Legacy NDC, 5 package rows | 20150720_1b439a3a-3199-43fd-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45865-357-20 | 45865035720 | 20 in 1 BOTTLE | Historical |
| 45865-357-30 | 45865035730 | 30 in 1 BOTTLE | Historical |
| 45865-357-51 | 45865035751 | 120 in 1 BOTTLE | Historical |
| 45865-357-60 | 45865035760 | 60 in 1 BOTTLE | Historical |
| 45865-357-90 | 45865035790 | 90 in 1 BOTTLE | Historical |