NDC codes

FDA NDC Directory
Product NDC (as listed)71205-740Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0740Add 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
71205-740-15712050740157120507401515 TABLET, FILM COATED in 1 BOTTLE (71205-740-15)Marketed from Dec 12, 2023
71205-740-20712050740207120507402020 TABLET, FILM COATED in 1 BOTTLE (71205-740-20)Marketed from Mar 12, 2024
71205-740-30712050740307120507403030 TABLET, FILM COATED in 1 BOTTLE (71205-740-30)Marketed from Sep 19, 2023
71205-740-40712050740407120507404040 TABLET, FILM COATED in 1 BOTTLE (71205-740-40)Marketed from Feb 7, 2024
71205-740-60712050740607120507406060 TABLET, FILM COATED in 1 BOTTLE (71205-740-60)Marketed from Sep 19, 2023
71205-740-727120507407271205074072120 TABLET, FILM COATED in 1 BOTTLE (71205-740-72)Marketed from Apr 8, 2024
71205-740-787120507407871205074078180 TABLET, FILM COATED in 1 BOTTLE (71205-740-78)Marketed from Oct 20, 2023
71205-740-90712050740907120507409090 TABLET, FILM COATED in 1 BOTTLE (71205-740-90)Marketed from Sep 19, 2023

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
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203494
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 71205-740_39d70777-2751-4f9e-a26b-675027a634c6SPL ID 39d70777-2751-4f9e-a26b-675027a634c6SPL set ID e90d4ef3-8b90-41b7-bf96-340852e89b5fRxCUI 835603UNII 9N7R477WCKUPC 0371205740900
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

N471205074015 followed by a unit qualifier and the quantity

Package 71205-0740-15. 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, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • 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 should n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-740

What is NDC 71205-740?
71205-740 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 8 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?
Proficient Rx LP, NDC labeler code 71205. 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 203494

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

FDA NDC Directory listings under ANDA 203494
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-716
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-441
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-772

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