What is NDC 72189-057?

72189-057 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.

DIRECT RX, 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 Bupropion Hydrochloride?

171 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupropion Hydrochloride NDC 72189-057

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0057Add 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
72189-057-30	7218900573072189005730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-057-30)Marketed from Nov 8, 2019
72189-057-60	7218900576072189005760	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-057-60)Marketed from Nov 8, 2019

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): Bupropion Hydrochloride
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202304
Marketing start: Nov 8, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 72189-057_2c4ea3ff-7a39-c7f4-e063-6294a90a5746SPL ID 2c4ea3ff-7a39-c7f4-e063-6294a90a5746SPL set ID 96d87edc-d12b-44b2-e053-2995a90a4e63RxCUI 993503, 993541, 993557UNII ZG7E5POY8O
Pharmacologic class: Aminoketone

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

N472189005730 followed by a unit qualifier and the quantity

Package 72189-0057-30. 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 Jan 22, 2025.

Indications (excerpt from the label)

Bupropion Hydrochloride Extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see CLINICAL STUDIES (14)]. The efficacy of Bupropion Hydrochloride Extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see CLINICAL STUDIES (14)].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-057

What is NDC 72189-057?: 72189-057 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bupropion Hydrochloride.
What is the active ingredient?: Bupropion hydrochloride.
Who is the labeler?: DIRECT RX, 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 Bupropion Hydrochloride?: 171 other product NDCs are listed under this name. See all Bupropion 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 Bupropion Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4739	70518-4739-00
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1143	67046-1143-03
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	59651-511	59651-0511-0559651-0511-3059651-0511-90
Bupropion Hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	59651-512	59651-0512-0559651-0512-3059651-0512-90
Bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1273	67046-1273-03
Bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-014	87441-0014-01
bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4674	70518-4674-0070518-4674-0170518-4674-02
Bupropion Hydrochloride	Bupropion hydrochloride 75 mg/1	Tablet, Film coatedOral	Amici Pharma, Inc.	69292-601	69292-0601-01
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Amici Pharma, Inc.	69292-602	69292-0602-01
bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1672	67046-1672-03

All 172 Bupropion Hydrochloride NDCs

Other NDCs under ANDA 202304

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

FDA NDC Directory listings under ANDA 202304
Product	Strength	Form · route	Labeler	Product NDC
bupropionbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0801
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-7099
bupropionbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-565
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	Solco Healthcare US LLC	43547-288
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Solco Healthcare US LLC	43547-289
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Film coated, Extended releaseOral	Solco Healthcare US LLC	43547-290
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-7465
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health 107, LLC	55154-0183
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-4591
bupropion hydrochloride SRbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	QPharma Inc	42708-205
bupropionbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Northwind Health Company, LLC	51655-357