What is NDC 68071-3644?

68071-3644 is the product NDC for tramadol hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 68071-3644

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3644Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3644Add 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
68071-3644-3	6807136440368071364403	30 TABLET in 1 PACKAGE (68071-3644-3)Marketed from Jul 9, 2024
68071-3644-4	6807136440468071364404	40 TABLET in 1 PACKAGE (68071-3644-4)Marketed from Sep 10, 2024
68071-3644-5	6807136440568071364405	15 TABLET in 1 PACKAGE (68071-3644-5)Marketed from Jul 9, 2024
68071-3644-6	6807136440668071364406	60 TABLET in 1 PACKAGE (68071-3644-6)Marketed from Sep 3, 2024
68071-3644-9	6807136440968071364409	90 TABLET in 1 PACKAGE (68071-3644-9)Marketed from Jul 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202075
Marketing start: Mar 1, 2018
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68071-3644_23aab36b-87f1-4569-e063-6394a90aae17SPL ID 23aab36b-87f1-4569-e063-6394a90aae17SPL set ID 1cd3caee-bf54-7aba-e063-6394a90ad8cbRxCUI 835603UNII 9N7R477WCKUPC 0368071364491
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

N468071364403 followed by a unit qualifier and the quantity

Package 68071-3644-03. 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 Oct 4, 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 ( 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, (1) Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1) Tramadol hydrochloride tablets should not be used for an extended…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3644

What is NDC 68071-3644?: 68071-3644 is the product NDC for tramadol hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 5 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?: NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 202075

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

FDA NDC Directory listings under ANDA 202075
Product	Strength	Form · route	Labeler	Product NDC
tramadol hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-778
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-791
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3655
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8717
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4248
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2518
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2612
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Proficient Rx LP	82804-114
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Northwind Health Company, LLC	82868-052