What is NDC 68382-354?

68382-354 is the product NDC for bupropion, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

bupropion NDC 68382-354 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-354Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0354Add 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
68382-354-05	6838203540568382035405	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-05)Marketed from Feb 15, 2014
68382-354-06	6838203540668382035406	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-06)Marketed from Feb 15, 2014
68382-354-10	6838203541068382035410	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-10)Marketed from Feb 15, 2014
68382-354-16	6838203541668382035416	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-16)Marketed from Feb 15, 2014

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
Generic name (nonproprietary): bupropion
Active ingredients: Bupropion hydrochloride — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201567
Marketing start: Feb 15, 2014
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 68382-354_71a16896-c3d0-4257-a48d-760baeb0a6b1SPL ID 71a16896-c3d0-4257-a48d-760baeb0a6b1
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

N468382035405 followed by a unit qualifier and the quantity

Package 68382-0354-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68382-354

What is NDC 68382-354?: 68382-354 is the product NDC for bupropion, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: bupropion.
What is the active ingredient?: Bupropion hydrochloride.
Who is the labeler?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?: 7 other product NDCs are listed under this name. See all bupropion 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
bupropionbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Film coated, Extended releaseOral	Northwind Health Company, LLC	51655-357	51655-0357-2651655-0357-52
bupropion	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-836	65841-0836-0565841-0836-0665841-0836-10+1 more
bupropion	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-353	68382-0353-0568382-0353-0668382-0353-10+1 more
bupropionbupropion hydrochloride	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-565	71205-0565-3071205-0565-6071205-0565-90
bupropionbupropion hydrochloride	Bupropion hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0801	71335-0801-0171335-0801-0271335-0801-03+3 more
bupropion	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-521	63187-0521-3063187-0521-6063187-0521-90
bupropion	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-780	65841-0780-0565841-0780-0665841-0780-10+1 more

Other NDCs under ANDA 201567

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

FDA NDC Directory listings under ANDA 201567
Product	Strength	Form · route	Labeler	Product NDC
bupropion	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-521
bupropion	Bupropion hydrochloride 300 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-780
bupropion	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	65841-836
bupropion	Bupropion hydrochloride 150 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-353