Prescription drug · ANDA
Tramadol Hydrochloride NDC 70518-4790
Tramadol hydrochloride 50 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4790-0 | 7051847900070518479000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4790-0)Marketed from Nov 3, 2026 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075968
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70518-4790_5f5f632c-b608-a77a-e063-6394a90a6eeaSPL ID 5f5f632c-b608-a77a-e063-6394a90a6eeaSPL set ID ccb3e0f9-57db-40bc-84d2-b66a827a5b96UNII 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.
- NDC on a medical claim
N470518479000followed by a unit qualifier and the quantityPackage 70518-4790-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride tablets are an opioid agonist indicated in adults f…
Excerpt only. Read the full label for complete information.
About NDC 70518-4790
- What is NDC 70518-4790?
- 70518-4790 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 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 |
| 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 |
Other NDCs under ANDA 075968
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 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-727 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-614 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-663 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4114 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3147 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0588 |