TRAMADOL HYDROCHLORIDE
- Product NDC
- 47335-861
- 11-digit product format
- 473350861
- Labeler code
- 47335
- Product ID
- 47335-861_a994e116-d201-47f9-baaf-dd76a84eba7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2011-12-12
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRAMADOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 833709, 833711, 833713 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-861-08 | TRAMADOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 24 |
| 47335-861-18 | TRAMADOL HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 24 |
| 47335-861-83 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 24 |
| 47335-861-88 | TRAMADOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| CELLULOSE ACETATE | INACTIVE INGREDIENT | 3J2P07GVB6 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-861 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 21 | Current NDC, Legacy NDC, 4 package rows | 20231213_004de5a4-80f8-4040-a6ea-be5e99352a36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-861-08 | 47335086108 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-08) | 2011-12-12 | 0000-00-00 | No | No | Current |
| 47335-861-18 | 47335086118 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-18) | 2011-12-12 | 0000-00-00 | No | No | Current |
| 47335-861-83 | 47335086183 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-83) | 2011-12-12 | 0000-00-00 | No | No | Current |
| 47335-861-88 | 47335086188 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-88) | 2011-12-12 | 0000-00-00 | No | No | Current |