What is NDC 71610-006?

71610-006 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 27 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 71610-006

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-006Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0006Add 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
71610-006-15	7161000061571610000615	15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15)Marketed from Oct 6, 2017
71610-006-20	7161000062071610000620	20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20)Marketed from Oct 6, 2017
71610-006-24	7161000062471610000624	224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24)Marketed from Oct 6, 2017
71610-006-28	7161000062871610000628	28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28)Marketed from Oct 6, 2017
71610-006-30	7161000063071610000630	30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30)Marketed from Oct 6, 2017
71610-006-40	7161000064071610000640	40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40)Marketed from Oct 6, 2017
71610-006-45	7161000064571610000645	45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45)Marketed from Oct 6, 2017
71610-006-46	7161000064671610000646	56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46)Marketed from Oct 6, 2017
71610-006-48	7161000064871610000648	480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48)Marketed from Oct 6, 2017
71610-006-50	7161000065071610000650	50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50)Marketed from Oct 6, 2017
71610-006-53	7161000065371610000653	60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53)Marketed from Oct 6, 2017
71610-006-54	7161000065471610000654	84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54)Marketed from Oct 6, 2017
71610-006-57	7161000065771610000657	80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57)Marketed from Aug 24, 2017
71610-006-60	7161000066071610000660	90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60)Marketed from Oct 6, 2017
71610-006-65	7161000066571610000665	100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65)Marketed from Oct 6, 2017
71610-006-67	7161000066771610000667	168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67)Marketed from Oct 6, 2017
71610-006-70	7161000067071610000670	120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70)Marketed from Oct 6, 2017
71610-006-72	7161000067271610000672	112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72)Marketed from Oct 6, 2017
71610-006-73	7161000067371610000673	135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73)Marketed from Oct 6, 2017
71610-006-75	7161000067571610000675	150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75)Marketed from Oct 6, 2017
71610-006-80	7161000068071610000680	180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80)Marketed from Oct 6, 2017
71610-006-85	7161000068571610000685	200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85)Marketed from Oct 6, 2017
71610-006-89	7161000068971610000689	720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89)Marketed from Oct 6, 2017
71610-006-90	7161000069071610000690	240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90)Marketed from Oct 6, 2017
71610-006-92	7161000069271610000692	270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92)Marketed from Oct 6, 2017
71610-006-94	7161000069471610000694	360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94)Marketed from Oct 6, 2017
71610-006-98	7161000069871610000698	540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)Marketed from Oct 6, 2017

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: Aug 24, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71610-006_069eec8b-6cca-435c-9d3f-fbdc75a813a0SPL ID 069eec8b-6cca-435c-9d3f-fbdc75a813a0SPL set ID bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18eRxCUI 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

N471610000615 followed by a unit qualifier and the quantity

Package 71610-0006-15. 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 Apr 4, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated for the management of pain in adults that is 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 ), 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-006

What is NDC 71610-006?: 71610-006 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 27 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	71610-865