NDC codes

FDA NDC Directory
Product NDC (as listed)64980-663Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0663Add 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
64980-663-016498006630164980066301100 TABLET in 1 BOTTLE (64980-663-01)Marketed from Oct 24, 2024

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 — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075968
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 64980-663_4a3ae814-06d8-4776-893b-db30c3d19ab6SPL ID 4a3ae814-06d8-4776-893b-db30c3d19ab6SPL set ID b5852b90-e415-47ef-8f73-87266b58e033RxCUI 835603, 2179635UNII 9N7R477WCKUPC 0364980663014
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

N464980066301 followed by a unit qualifier and the quantity

Package 64980-0663-01. 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 . 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, overdose, 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 adults f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-663

What is NDC 64980-663?
64980-663 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 100 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tramadol Hydrochloride.
What is the active ingredient?
Tramadol hydrochloride.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 Hydrochloride?
112 other product NDCs are listed under this name. See all Tramadol Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tramadol Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-479070518-4790-00
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1TabletOralRising Pharma Holdings, Inc.64980-71764980-0717-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralUnit Dose Solutions, Inc.87441-08987441-0089-01
tramadol hydrochlorideTramadol hydrochloride 25 mg/1TabletOralStrides Pharma Science Limited64380-77864380-0778-01
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-471370518-4713-0070518-4713-0170518-4713-02+1 more
tramadol hydrochlorideTramadol hydrochloride 50 mg/1TabletOralStrides Pharma Science Limited64380-79164380-0791-0164380-0791-0264380-0791-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-058880425-0588-0180425-0588-0280425-0588-03+5 more
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-11082868-0110-30
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralCoupler LLC67046-120967046-1209-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-411468788-4114-0168788-4114-0268788-4114-03+5 more

All 113 Tramadol Hydrochloride NDCs

Other NDCs under ANDA 075968

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

FDA NDC Directory listings under ANDA 075968
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-727
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralRising Pharma Holdings, Inc.64980-614
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4114
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralBryant Ranch Prepack71335-3147
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0588

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