What is NDC 76420-245?

76420-245 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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 76420-245

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0245Add 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
76420-245-30	7642002453076420024530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-30)Marketed from Jul 25, 2022
76420-245-60	7642002456076420024560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-60)Marketed from Jul 25, 2022
76420-245-90	7642002459076420024590	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-90)Marketed from Jul 25, 2022

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 — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201384
Marketing start: Dec 12, 2011
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 76420-245_e49bb4f0-8b07-c774-e053-2a95a90acff7SPL ID e49bb4f0-8b07-c774-e053-2a95a90acff7SPL set ID dce0d21e-e4c2-4875-a2ce-9d53df190b80RxCUI 833709, 833711, 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

N476420024530 followed by a unit qualifier and the quantity

Package 76420-0245-30. 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 Jul 25, 2022. 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 otherw…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-245

What is NDC 76420-245?: 76420-245 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 3 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?: Asclemed USA, Inc., NDC labeler code 76420. 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 201384

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

FDA NDC Directory listings under ANDA 201384
Product	Strength	Form · route	Labeler	Product NDC
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0141
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-859
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-860
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-861
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	DIRECT RX	61919-893
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-597
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8324
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-656
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-708
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1675
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1676
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-244
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-246