What is NDC 68071-5078?

68071-5078 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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 68071-5078

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-5078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-5078Add 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	Copy
68071-5078-3	6807150780368071507803	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5078-3)Marketed from Oct 1, 2019

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 — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200503
Marketing start: Aug 18, 2014
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68071-5078_1b466cdb-e4a9-9564-e063-6394a90add37SPL ID 1b466cdb-e4a9-9564-e063-6394a90add37SPL set ID 93e129c8-64c4-1f6d-e053-2a95a90ac1f8RxCUI 833713UNII 9N7R477WCKUPC 0368071507836
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

N468071507803 followed by a unit qualifier and the quantity

Package 68071-5078-03. 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 Jun 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be other…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-5078

What is NDC 68071-5078?: 68071-5078 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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 200503

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

FDA NDC Directory listings under ANDA 200503
Product	Strength	Form · route	Labeler	Product NDC
Tramadol HCl ERtramadol hcl	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	DIRECT RX	61919-818
Tramadol HCL ER	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-521
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0108
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0136
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0312
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Medsource Pharmaceuticals	45865-184
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-5107
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Quality Care Products, LLC	55700-996
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8319
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8323
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1527
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-1671
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-383
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-384
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-385
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-697
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-698
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-699
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-7601
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-8367

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