Prescription drug · ANDA

Tramadol Hydrochloride NDC 52817-195

Tramadol hydrochloride 50 mg/1 · Tablet, Coated · Oral · TRUPHARMA LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)52817-195Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52817-0195Add 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
52817-195-00528170195001000 TABLET, COATED in 1 BOTTLE (52817-195-00)Marketed from Sep 1, 2020
52817-195-1052817019510100 TABLET, COATED in 1 BOTTLE (52817-195-10)Marketed from Sep 1, 2020
52817-195-5052817019550500 TABLET, COATED in 1 BOTTLE (52817-195-50)Marketed from Sep 1, 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, Coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208708
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 52817-195_bb37b29d-c827-d710-e053-2995a90acf1dSPL ID bb37b29d-c827-d710-e053-2995a90acf1dSPL set ID 61fb5ba7-6896-4ee4-83de-caee69b06a8eRxCUI 835603, 2179635UNII 9N7R477WCKUPC 0352817196101, 0352817196002, 0352817195005, 0352817196507, 0352817195500, 0352817195104
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

N452817019500 followed by a unit qualifier and the quantity

Package 52817-0195-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride tablets, USP 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 is an opioid agonist indicated in adults for the manag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208708

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

FDA NDC Directory listings under ANDA 208708
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4713
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralProficient Rx LP82804-142
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-8121
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-008
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralCoupler LLC67046-1541
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-732
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-733
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-734
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0274
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralTRUPHARMA LLC52817-196
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0276
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-2721
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-080
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-9658
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3824
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-110
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralDirectRx72189-311
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-162
Tramadol HydrochlorideTramadol hydrochloride 75 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-163
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralRedPharm Drug Inc67296-1834

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Tramadol Hydrochloride NDC 52817-195 | Med-Code