What is NDC 46708-118?

46708-118 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-118

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-118Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0118Add 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
46708-118-31	4670801183146708011831	100 TABLET, FILM COATED in 1 BOTTLE (46708-118-31)Marketed from Jun 18, 2018
46708-118-91	4670801189146708011891	1000 TABLET, FILM COATED in 1 BOTTLE (46708-118-91)Marketed from Jun 18, 2018

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 — 75 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203013
Marketing start: Jun 18, 2018
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 46708-118_b09bdaa7-0871-4741-b5cd-dd30d683613cSPL ID b09bdaa7-0871-4741-b5cd-dd30d683613cSPL set ID ef0bb8f2-7710-4236-8b47-57b74c8bca3eRxCUI 993687, 993691UNII ZG7E5POY8OUPC 0346708127312, 0346708118310
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

N446708011831 followed by a unit qualifier and the quantity

Package 46708-0118-31. 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 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets USP 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)] . Bupropion hydrochloride tablets USP are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-118

What is NDC 46708-118?: 46708-118 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 203013

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

FDA NDC Directory listings under ANDA 203013
Product	Strength	Form · route	Labeler	Product NDC
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-127
Bupropion Hydrochloride	Bupropion hydrochloride 75 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-118
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-127
Bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4218
Bupropion Hydrochloride	Bupropion hydrochloride 75 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4264