Tramadol Hydrochloride NDC 60760-772

NDC codes

FDA NDC Directory

Product NDC (as listed)60760-772Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60760-0772Add 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
60760-772-09	60760077209	9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-09)Marketed from Dec 28, 2022
60760-772-20	60760077220	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-20)Marketed from Feb 2, 2023
60760-772-30	60760077230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-30)Marketed from Dec 28, 2022
60760-772-60	60760077260	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-60)Marketed from Feb 2, 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: ST. MARY'S MEDICAL PARK PHARMACY
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203494
Marketing start: Dec 28, 2022
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 60760-772_50c7ea1f-6612-746d-e063-6394a90a9f24SPL ID 50c7ea1f-6612-746d-e063-6394a90a9f24SPL set ID f2f421ab-35ae-7637-e053-2995a90a40e0RxCUI 835603UNII 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

N460760077209 followed by a unit qualifier and the quantity

Package 60760-0772-09. 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 May 1, 2026. 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, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 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 are an opioid agonist indicated in adults for the managemen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203494

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203494
Product	Strength	Form · route	Labeler	Product NDC
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	Rising Pharma Holdings, Inc.	16571-716
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-740