What is NDC 70518-2795?

70518-2795 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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 70518-2795 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-2795Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-2795Add 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
70518-2795-0	70518279500	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2795-0)Marketed from Jun 24, 2020

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: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200503
Marketing start: Jun 24, 2020
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 70518-2795_4e412f24-05d3-b5a2-e063-6394a90adf5bSPL ID 4e412f24-05d3-b5a2-e063-6394a90adf5bSPL set ID b76c1366-f6c0-42ad-bb19-2b72a91490e4RxCUI 833713UNII 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

N470518279500 followed by a unit qualifier and the quantity

Package 70518-2795-00. 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 Mar 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosages or duration, and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-2795

What is NDC 70518-2795?: 70518-2795 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK 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?: REMEDYREPACK INC., NDC labeler code 70518. 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	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
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-727	60760-0727-0960760-0727-2060760-0727-30+5 more
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4040	68788-4040-0168788-4040-0268788-4040-03+6 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 Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8323
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8319
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-569
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Quality Care Products, LLC	55700-996
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-5078
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-0886
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-0942
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Medsource Pharmaceuticals	45865-184
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-699
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 200 mg/1	Tablet, Extended releaseOral	DIRECT RX	72189-154
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1527
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0312
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	Proficient Rx LP	71205-463
Tramadol HCL ER	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Direct_Rx	72189-521
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-468
Tramadol HCl ERtramadol hcl	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	DIRECT RX	61919-818
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-9670

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