What is NDC 68071-4119?

68071-4119 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 8 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 68071-4119

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4119Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4119Add 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
68071-4119-1	6807141190168071411901	120 TABLET, COATED in 1 BOTTLE (68071-4119-1)Marketed from Oct 16, 2017
68071-4119-3	6807141190368071411903	30 TABLET, COATED in 1 BOTTLE (68071-4119-3)Marketed from Oct 16, 2017
68071-4119-4	6807141190468071411904	40 TABLET, COATED in 1 BOTTLE (68071-4119-4)Marketed from Oct 16, 2017
68071-4119-5	6807141190568071411905	15 TABLET, COATED in 1 BOTTLE (68071-4119-5)Marketed from Oct 16, 2017
68071-4119-6	6807141190668071411906	60 TABLET, COATED in 1 BOTTLE (68071-4119-6)Marketed from Oct 16, 2017
68071-4119-7	6807141190768071411907	84 TABLET, COATED in 1 BOTTLE (68071-4119-7)Marketed from Oct 16, 2017
68071-4119-8	6807141190868071411908	180 TABLET, COATED in 1 BOTTLE (68071-4119-8)Marketed from Oct 16, 2017
68071-4119-9	6807141190968071411909	90 TABLET, COATED in 1 BOTTLE (68071-4119-9)Marketed from Oct 16, 2017

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, Coated
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076003
Marketing start: Nov 15, 2010
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68071-4119_2d3fca70-2bc9-7bec-e063-6294a90a8da4SPL ID 2d3fca70-2bc9-7bec-e063-6294a90a8da4SPL set ID 5babcfcf-331b-5db9-e053-2a91aa0aaf89RxCUI 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

N468071411901 followed by a unit qualifier and the quantity

Package 68071-4119-01. 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 Feb 3, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tramadol HCl 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 HCl 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 68071-4119

What is NDC 68071-4119?: 68071-4119 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?: 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 076003

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

FDA NDC Directory listings under ANDA 076003
Product	Strength	Form · route	Labeler	Product NDC
Tramadol HCL	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0057
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Major Pharmaceuticals	0904-7496
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Clinical Solutions Wholesale, LLC	58118-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals NY LLC	60219-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	American Health Packaging	60687-795
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	63187-063
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals LLC	65162-627
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1209
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Amneal Pharmaceuticals NY LLC	69238-2348
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0501
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Unit Dose Solutions, Inc.	87441-089