What is NDC 80425-0057?

80425-0057 is the product NDC for Tramadol HCL, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 HCL?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tramadol HCL NDC 80425-0057 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0057Add 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
80425-0057-1	8042500570180425005701	30 TABLET, COATED in 1 BOTTLE (80425-0057-1)Marketed from Nov 15, 2010
80425-0057-2	8042500570280425005702	60 TABLET, COATED in 1 BOTTLE (80425-0057-2)Marketed from Nov 15, 2010
80425-0057-3	8042500570380425005703	90 TABLET, COATED in 1 BOTTLE (80425-0057-3)Marketed from Nov 15, 2010
80425-0057-4	8042500570480425005704	15 TABLET, COATED in 1 BOTTLE (80425-0057-4)Marketed from Nov 15, 2010
80425-0057-5	8042500570580425005705	120 TABLET, COATED in 1 BOTTLE (80425-0057-5)Marketed from Nov 15, 2010

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 HCL
Generic name (nonproprietary): tramadol hcl
Active ingredients: Tramadol hydrochloride — 50 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076003
Marketing start: Nov 15, 2010
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33bSPL ID 2a98da36-e8b2-759b-e063-6294a90ab33bSPL set ID af87fc31-07c2-b1f7-e053-2995a90a499fRxCUI 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

N480425005701 followed by a unit qualifier and the quantity

Package 80425-0057-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0057

What is NDC 80425-0057?: 80425-0057 is the product NDC for Tramadol HCL, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tramadol HCL.
What is the active ingredient?: Tramadol hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 HCL?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 076003

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

FDA NDC Directory listings under ANDA 076003
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Major Pharmaceuticals	0904-7496
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Clinical Solutions Wholesale, LLC	58118-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals NY LLC	60219-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	American Health Packaging	60687-795
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	63187-063
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals LLC	65162-627
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1209
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	NuCare Pharmaceuticals,Inc.	68071-4119
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals NY LLC	69238-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0501
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Unit Dose Solutions, Inc.	87441-089