Prescription drug · ANDA
Tramadol Hydrochloride NDC 68180-385
Tramadol hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68180-385Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0385Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Tramadol Hydrochloride
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200503
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68180-385_e674f8e1-d70a-4e39-b2c3-6b7ad77e3796SPL ID e674f8e1-d70a-4e39-b2c3-6b7ad77e3796SPL set ID 3e0ccb95-3e8e-477c-b4d2-6060ee05f930RxCUI 833709, 833711, 833713UNII 9N7R477WCK
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Excerpt only. Read the full label for complete information.
About NDC 68180-385
- What is NDC 68180-385?
- 68180-385 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Tramadol Hydrochloride.
- What is the active ingredient?
- Tramadol hydrochloride.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tramadol Hydrochloride?
- 113 other product NDCs are listed under this name. See all Tramadol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tramadol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Unit Dose Solutions, Inc. | 87441-089 | 87441-0089-01 |
| tramadol hydrochloride | Tramadol hydrochloride 25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-778 | 64380-0778-01 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-4713 | 70518-4713-0070518-4713-0170518-4713-02+1 more |
| tramadol hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-791 | 64380-0791-0164380-0791-0264380-0791-03 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0588 | 80425-0588-0180425-0588-0280425-0588-03+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-110 | 82868-0110-30 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1209 | 67046-1209-03 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4114 | 68788-4114-0168788-4114-0268788-4114-03+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-727 | 60760-0727-0960760-0727-2060760-0727-30+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4040 | 68788-4040-0168788-4040-0268788-4040-03+6 more |
Other NDCs under ANDA 200503
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-536 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-537 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Quality Care Products, LLC | 83008-009 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-538 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0108 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7601 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-463 |
| Tramadol HCL ER | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-521 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-468 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0136 |
| Tramadol HCl ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 61919-818 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9670 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8367 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-383 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5107 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-384 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2795 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Quality Care Products, LLC | 55700-996 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-1671 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-569 |
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