What is NDC 33342-270?

33342-270 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 200 mg/1 tablet, film coated, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?

113 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 33342-270 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0270Add 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
33342-270-07	33342027007	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-270-07)Marketed from Jan 31, 2025
33342-270-10	33342027010	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-270-10)Marketed from Jan 31, 2025
33342-270-11	33342027011	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-270-11)Marketed from Jan 31, 2025

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, Film coated, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209404
Marketing start: Jan 31, 2025
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 33342-270_0f59cb5b-586f-41de-866f-e2386f4d0178SPL ID 0f59cb5b-586f-41de-866f-e2386f4d0178SPL set ID a07ed444-54e4-4d45-b6a1-6ea2f6dedc61RxCUI 833709, 833711, 833713UNII 9N7R477WCKUPC 0333342271112, 0333342269119
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

N433342027007 followed by a unit qualifier and the quantity

Package 33342-0270-07. 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 Dec 5, 2025. 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 of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-270

What is NDC 33342-270?: 33342-270 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 200 mg/1 tablet, film coated, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?: 113 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 114 Tramadol Hydrochloride NDCs

Other NDCs under ANDA 209404

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

FDA NDC Directory listings under ANDA 209404
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-269
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-271
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	82804-298