Prescription drug · ANDA

Tramadol Hydrochloride NDC 60219-2348

Tramadol hydrochloride 50 mg/1 · Tablet, Coated · Oral · Amneal Pharmaceuticals NY LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)60219-2348Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60219-2348Add 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 NDC11-digit (billing)PackageCopy
60219-2348-160219234801100 TABLET, COATED in 1 BOTTLE (60219-2348-1)Marketed from Feb 13, 2023
60219-2348-46021923480410 TABLET, COATED in 1 BOTTLE (60219-2348-4)Marketed from Feb 13, 2023
60219-2348-560219234805500 TABLET, COATED in 1 BOTTLE (60219-2348-5)Marketed from Feb 13, 2023
60219-2348-7602192348071000 TABLET, COATED in 1 BOTTLE (60219-2348-7)Marketed from Feb 13, 2023

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 Hydrochloride
Generic name (nonproprietary)
tramadol hydrochloride
Active ingredients
Tramadol hydrochloride — 50 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076003
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 60219-2348_79085c00-c075-4513-81d1-967e9041d0d9SPL ID 79085c00-c075-4513-81d1-967e9041d0d9
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

N460219234801 followed by a unit qualifier and the quantity

Package 60219-2348-01. 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

The FDA listing for this product does not reference a label (SPL) set.

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
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-627
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx of Tennessee, LLC80425-0501
Tramadol HCLTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx of Tennessee, LLC80425-0057
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralMajor Pharmaceuticals0904-7496
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralClinical Solutions Wholesale, LLC58118-2348
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralProficient Rx LP63187-063
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-4119
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralCoupler LLC67046-1209
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAmneal Pharmaceuticals NY LLC69238-2348
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAmerican Health Packaging60687-795

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Tramadol Hydrochloride NDC 60219-2348 | Med-Code