What is NDC 69097-072?

69097-072 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, film coated, extended release, listed with the FDA by Cipla USA., Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA., Inc., NDC labeler code 69097. 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 69097-072

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-072Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0072Add 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
69097-072-12	6909700721269097007212	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-072-12)Marketed from Oct 25, 2023

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 — 300 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Cipla USA., Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207479
Marketing start: Oct 25, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 69097-072_9c292b5a-2a09-4f01-b1fe-8652dd577542SPL ID 9c292b5a-2a09-4f01-b1fe-8652dd577542SPL set ID 0abd64f7-5142-48f6-a487-3f5bdc3400deRxCUI 993541, 993557UNII ZG7E5POY8OUPC 0369097072124, 0369097071127
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

N469097007212 followed by a unit qualifier and the quantity

Package 69097-0072-12. 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 Oct 19, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: • treatment of major depressive disorder (MDD) ( 1.1 ) • prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the main…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-072

What is NDC 69097-072?: 69097-072 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, film coated, extended release, listed with the FDA by Cipla USA., Inc.. It has 1 package NDC, 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?: Cipla USA., Inc., NDC labeler code 69097. 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 207479

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

FDA NDC Directory listings under ANDA 207479
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7711
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7712
Bupropion Hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Cipla USA., Inc.	69097-071
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Dr Reddys Laboratories Inc	43598-655
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Dr Reddys Laboratories Inc	43598-656
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7334
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7335
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals,Inc.	50228-144
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals,Inc.	50228-145
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-8474
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-8475
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-8476
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	NuCare Pharmaceuticals, Inc.	68071-3927
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4172
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-3790
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	REMEDYREPACK INC.	70518-3963
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2312
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-1526
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 300 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-1527
Bupropion Hydrochloride (XL)bupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	RADHA PHARMACEUTICALS, INC.	77771-144

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