Tramadol Hydrochloride NDC 59651-441

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0441Add 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
59651-441-01	59651044101	100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01)Marketed from Sep 23, 2020
59651-441-05	59651044105	500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05)Marketed from Sep 23, 2020
59651-441-99	59651044199	1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99)Marketed from Sep 23, 2020

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203494
Marketing start: Sep 23, 2020
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 59651-441_2bc49f6b-9351-405e-a91b-abd13632c0b3SPL ID 2bc49f6b-9351-405e-a91b-abd13632c0b3SPL set ID e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3fRxCUI 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

N459651044101 followed by a unit qualifier and the quantity

Package 59651-0441-01. 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 Aug 25, 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, misuse, ov erdo se, 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 adult…

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	ST. MARY'S MEDICAL PARK PHARMACY	60760-772
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