Prescription drug · ANDA
Tramadol Hydrochloride NDC 71205-740
Tramadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-740-15 | 7120507401571205074015 | 15 TABLET, FILM COATED in 1 BOTTLE (71205-740-15)Marketed from Dec 12, 2023 | |
| 71205-740-20 | 7120507402071205074020 | 20 TABLET, FILM COATED in 1 BOTTLE (71205-740-20)Marketed from Mar 12, 2024 | |
| 71205-740-30 | 7120507403071205074030 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-740-30)Marketed from Sep 19, 2023 | |
| 71205-740-40 | 7120507404071205074040 | 40 TABLET, FILM COATED in 1 BOTTLE (71205-740-40)Marketed from Feb 7, 2024 | |
| 71205-740-60 | 7120507406071205074060 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-740-60)Marketed from Sep 19, 2023 | |
| 71205-740-72 | 7120507407271205074072 | 120 TABLET, FILM COATED in 1 BOTTLE (71205-740-72)Marketed from Apr 8, 2024 | |
| 71205-740-78 | 7120507407871205074078 | 180 TABLET, FILM COATED in 1 BOTTLE (71205-740-78)Marketed from Oct 20, 2023 | |
| 71205-740-90 | 7120507409071205074090 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-740-90)Marketed from Sep 19, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203494
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71205-740_39d70777-2751-4f9e-a26b-675027a634c6SPL ID 39d70777-2751-4f9e-a26b-675027a634c6SPL set ID e90d4ef3-8b90-41b7-bf96-340852e89b5fRxCUI 835603UNII 9N7R477WCKUPC 0371205740900
- 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
N471205074015followed by a unit qualifier and the quantityPackage 71205-0740-15. 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, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets should n…
Excerpt only. Read the full label for complete information.
About NDC 71205-740
- What is NDC 71205-740?
- 71205-740 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 8 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?
- Proficient Rx LP, NDC labeler code 71205. 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 203494
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 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-716 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-441 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-772 |