Tramadol Hydrochloride NDC 52817-615

NDC codes

FDA NDC Directory

Product NDC (as listed)52817-615Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52817-0615Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
52817-615-16	52817061516	473 mL in 1 BOTTLE (52817-615-16)Marketed from Jan 25, 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 — 5 mg/mL
Dosage form: Solution
Route: Oral
Labeler: TruPharma, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 214044
Marketing start: Sep 11, 2020
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 52817-615_f7fd27bd-cd40-704c-e053-6394a90a6a6fSPL ID f7fd27bd-cd40-704c-e053-6394a90a6a6fSPL set ID aea56ff9-94ac-47a8-8f15-8790d538973bRxCUI 2395808UNII 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

N452817061516 followed by a unit qualifier and the quantity

Package 52817-0615-16. 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 Jan 25, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Tramadol hydrochloride oral solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.2 ), reserve tramadol hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)