Tramadol Hydrochloride
- Product NDC
- 76519-1009
- 11-digit product format
- 765191009
- Labeler code
- 76519
- Product ID
- 76519-1009_f16375f3-737f-41b8-a412-6962874bd080
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA022370
- Marketing category
- NDA
- Marketing start
- 2012-03-14
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76519-1009-3 | Tramadol Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 1 |
| 76519-1009-5 | Tramadol Hydrochloride | 15 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 15 | | 1 |
| 76519-1009-6 | Tramadol Hydrochloride | 60 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
| 76519-1009-9 | Tramadol Hydrochloride | 90 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) | INACTIVE INGREDIENT | P2OM2Q86BI | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| SUCROSE STEARATE | INACTIVE INGREDIENT | 274KW0O50M | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1009 | TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 4 package rows | 20121026_e3476daa-2b3c-455e-b5c4-3c011e03315b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1009-3 | 76519100903 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 76519-1009-5 | 76519100905 | 15 in 1 BOTTLE, PLASTIC | Historical |
| 76519-1009-6 | 76519100906 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 76519-1009-9 | 76519100909 | 90 in 1 BOTTLE, PLASTIC | Historical |