What is NDC 72189-311?

72189-311 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by DirectRx. It has 9 package NDCs, shown above in 10- and 11-digit form.

DirectRx, NDC labeler code 72189. 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 72189-311

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-311Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0311Add 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
72189-311-12	7218903111272189031112	12 TABLET, COATED in 1 BOTTLE (72189-311-12)Marketed from Jan 12, 2022
72189-311-20	7218903112072189031120	20 TABLET, COATED in 1 BOTTLE (72189-311-20)Marketed from Jan 12, 2022
72189-311-30	7218903113072189031130	30 TABLET, COATED in 1 BOTTLE (72189-311-30)Marketed from Jan 12, 2022
72189-311-40	7218903114072189031140	40 TABLET, COATED in 1 BOTTLE (72189-311-40)Marketed from Jan 12, 2022
72189-311-60	7218903116072189031160	60 TABLET, COATED in 1 BOTTLE (72189-311-60)Marketed from Jan 12, 2022
72189-311-72	7218903117272189031172	120 TABLET, COATED in 1 BOTTLE (72189-311-72)Marketed from Jan 12, 2022
72189-311-82	7218903118272189031182	180 TABLET, COATED in 1 BOTTLE (72189-311-82)Marketed from Jan 12, 2022
72189-311-84	7218903118472189031184	240 TABLET, COATED in 1 BOTTLE (72189-311-84)Marketed from Jan 12, 2022
72189-311-90	7218903119072189031190	90 TABLET, COATED in 1 BOTTLE (72189-311-90)Marketed from Jan 12, 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 — 50 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: DirectRxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208708
Marketing start: Jan 12, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-311_2c3cf1d7-38f5-4d25-e063-6294a90aa8cdSPL ID 2c3cf1d7-38f5-4d25-e063-6294a90aa8cdSPL set ID d5685c80-c84d-d0a1-e053-2995a90afc54RxCUI 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

N472189031112 followed by a unit qualifier and the quantity

Package 72189-0311-12. 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 Jan 21, 2025.

Indications (excerpt from the label)

Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain 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 AND PRECAUTIONS (5.1)] , reserve tramadol hydrochloride 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 72189-311

What is NDC 72189-311?: 72189-311 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by DirectRx. It has 9 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?: DirectRx, NDC labeler code 72189. 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 208708

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

FDA NDC Directory listings under ANDA 208708
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Quality Care Products, LLC	55700-997
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Northwind Health Company, LLC	82868-110
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8121
Tramadol Hydrochloride	Tramadol hydrochloride 25 mg/1	Tablet, CoatedOral	Advagen Pharma Limited	72888-162
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3824
Tramadol Hydrochloride	Tramadol hydrochloride 75 mg/1	Tablet, CoatedOral	Advagen Pharma Limited	72888-163
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, CoatedOral	Asclemed USA, Inc.	76420-734
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1541
Tramadol Hydrochloride	Tramadol hydrochloride 25 mg/1	Tablet, CoatedOral	Asclemed USA, Inc.	76420-732
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Asclemed USA, Inc.	76420-733
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	82804-142
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	TRUPHARMA LLC	52817-195
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0276
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, CoatedOral	TRUPHARMA LLC	52817-196
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0274
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-4713
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, CoatedOral	Advagen Pharma Limited	72888-008
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-2721
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	RedPharm Drug Inc	67296-1834
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-9658

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