NDC codes

FDA NDC Directory
Product NDC (as listed)29300-355Labeler and product segments. Claims need a package NDC.
Product NDC at billing width29300-0355Add 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
29300-355-012930003550129300035501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-01)Marketed from Nov 4, 2019
29300-355-052930003550529300035505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-05)Marketed from Nov 4, 2019
29300-355-1029300035510293000355101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-10)Marketed from Nov 4, 2019

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
Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211825
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 29300-355_2e474886-5eb1-4fa0-b53e-04281e31b631SPL ID 2e474886-5eb1-4fa0-b53e-04281e31b631SPL set ID 007bf37f-0e46-426a-ac8c-be63d4b7414cRxCUI 835603UNII 9N7R477WCKUPC 0329300355017
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

N429300035501 followed by a unit qualifier and the quantity

Package 29300-0355-01. 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 ( 1 ). Limitations of Use ( 1 ) 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, reserve opioid analgesics, including tramadol hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain ( 1 , 5.1 ). Tramadol hydrochloride tablets are opioid agonist indicated in adults for the management of pain …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 29300-355

What is NDC 29300-355?
29300-355 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 package NDCs, 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?
Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 211825

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

FDA NDC Directory listings under ANDA 211825
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5789
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5790
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4035
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4040
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0548
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralAsclemed USA, Inc.87063-117

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