What is NDC 71610-865?

71610-865 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 23 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tramadol Hydrochloride NDC 71610-865

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-865Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0865Add 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 NDC	11-digit (billing)	Package
71610-865-15	7161008651571610086515	15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15)Marketed from Nov 18, 2024
71610-865-20	7161008652071610086520	20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20)Marketed from Nov 18, 2024
71610-865-24	7161008652471610086524	224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24)Marketed from Nov 18, 2024
71610-865-28	7161008652871610086528	28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28)Marketed from Nov 18, 2024
71610-865-30	7161008653071610086530	30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30)Marketed from Nov 18, 2024
71610-865-40	7161008654071610086540	40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40)Marketed from Nov 18, 2024
71610-865-45	7161008654571610086545	45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45)Marketed from Nov 18, 2024
71610-865-46	7161008654671610086546	56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46)Marketed from Nov 18, 2024
71610-865-50	7161008655071610086550	50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50)Marketed from Nov 18, 2024
71610-865-53	7161008655371610086553	60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53)Marketed from Nov 18, 2024
71610-865-54	7161008655471610086554	84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54)Marketed from Nov 18, 2024
71610-865-57	7161008655771610086557	80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57)Marketed from Nov 18, 2024
71610-865-60	7161008656071610086560	90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60)Marketed from Nov 18, 2024
71610-865-65	7161008656571610086565	100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65)Marketed from Nov 18, 2024
71610-865-67	7161008656771610086567	168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67)Marketed from Nov 18, 2024
71610-865-70	7161008657071610086570	120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70)Marketed from Nov 18, 2024
71610-865-72	7161008657271610086572	112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72)Marketed from Nov 18, 2024
71610-865-73	7161008657371610086573	135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73)Marketed from Nov 18, 2024
71610-865-75	7161008657571610086575	150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75)Marketed from Nov 18, 2024
71610-865-80	7161008658071610086580	180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80)Marketed from Nov 18, 2024
71610-865-85	7161008658571610086585	200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85)Marketed from Nov 18, 2024
71610-865-90	7161008659071610086590	240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90)Marketed from Nov 18, 2024
71610-865-92	7161008659271610086592	270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92)Marketed from Nov 18, 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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075977
Marketing start: Jun 19, 2002
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71610-865_27460b14-190b-94e9-e063-6394a90ae97fSPL ID 27460b14-190b-94e9-e063-6394a90ae97fSPL set ID 27460cc6-0782-7838-e063-6394a90a19f1RxCUI 835603UNII 9N7R477WCK
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

N471610086515 followed by a unit qualifier and the quantity

Package 71610-0865-15. 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 Nov 18, 2024. 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 not …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-865

What is NDC 71610-865?: 71610-865 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 23 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4790	70518-4790-00
Tramadol Hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-717	64980-0717-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Unit Dose Solutions, Inc.	87441-089	87441-0089-01
tramadol hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-778	64380-0778-01
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-4713	70518-4713-0070518-4713-0170518-4713-02+1 more
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-791	64380-0791-0164380-0791-0264380-0791-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0588	80425-0588-0180425-0588-0280425-0588-03+5 more
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Northwind Health Company, LLC	82868-110	82868-0110-30
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1209	67046-1209-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4114	68788-4114-0168788-4114-0268788-4114-03+5 more

All 113 Tramadol Hydrochloride NDCs

Other NDCs under ANDA 075977

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

FDA NDC Directory listings under ANDA 075977
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-3301
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-007
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-006