Prescription drug · ANDA
Tramadol Hydrochloride NDC 68788-7601
Tramadol hydrochloride 200 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-7601Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7601Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7601-2 | 6878876010268788760102 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-2)Marketed from Feb 6, 2020 | |
| 68788-7601-3 | 6878876010368788760103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-3)Marketed from Feb 6, 2020 | |
| 68788-7601-6 | 6878876010668788760106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-6)Marketed from Feb 6, 2020 | |
| 68788-7601-9 | 6878876010968788760109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-9)Marketed from Feb 6, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tramadol Hydrochloride
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-7601_fc437f44-261a-4b9d-a78a-c3478582d042SPL ID fc437f44-261a-4b9d-a78a-c3478582d042
- 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.
- NDC on a medical claim
N468788760102followed by a unit qualifier and the quantityPackage 68788-7601-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-7601
- What is NDC 68788-7601?
- 68788-7601 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tramadol Hydrochloride.
- What is the active ingredient?
- Tramadol hydrochloride.
- Who is the labeler?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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?
- 112 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 | TabletOral | REMEDYREPACK INC. | 70518-4790 | 70518-4790-00 |
| Tramadol Hydrochloride | Tramadol hydrochloride 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-717 | 64980-0717-03 |
| 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 |
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 HCl ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 61919-818 |
| Tramadol HCL ER | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-521 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0108 |
| 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 300 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0312 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Medsource Pharmaceuticals | 45865-184 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5107 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Quality Care Products, LLC | 55700-996 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-8319 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-8323 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1527 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-5078 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-383 |
| 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 | Lupin Pharmaceuticals, Inc. | 68180-385 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-697 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-698 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-699 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8367 |
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