Tramadol Hydrochloride
- Product NDC
- 10544-531
- 11-digit product format
- 105440531
- Labeler code
- 10544
- Product ID
- 10544-531_e273cf85-8544-4ea3-8019-057611a85f55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2010-04-07
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-531-06 | Tramadol Hydrochloride | 6 in 1 BOTTLE | TABLET | 6 | | 3 |
| 10544-531-10 | Tramadol Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 10544-531-15 | Tramadol Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
| 10544-531-20 | Tramadol Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 10544-531-30 | Tramadol Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 10544-531-50 | Tramadol Hydrochloride | 50 in 1 BOTTLE | TABLET | 50 | | 3 |
| 10544-531-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 10544-531-90 | Tramadol Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-531 | TRAMADOL HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 8 package rows | 20141201_58c2975a-47bd-4d3c-9cfe-9ea59f3f31ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-531-06 | 10544053106 | 6 in 1 BOTTLE | Historical |
| 10544-531-10 | 10544053110 | 10 in 1 BOTTLE | Historical |
| 10544-531-15 | 10544053115 | 15 in 1 BOTTLE | Historical |
| 10544-531-20 | 10544053120 | 20 in 1 BOTTLE | Historical |
| 10544-531-30 | 10544053130 | 30 in 1 BOTTLE | Historical |
| 10544-531-50 | 10544053150 | 50 in 1 BOTTLE | Historical |
| 10544-531-60 | 10544053160 | 60 in 1 BOTTLE | Historical |
| 10544-531-90 | 10544053190 | 90 in 1 BOTTLE | Historical |