NDC codes

FDA NDC Directory
Product NDC (as listed)68084-708Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0708Add 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 NDC11-digit (billing)PackageCopy
68084-708-25680840708256808407082530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-708-25) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-708-95)Marketed from Apr 1, 2015

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 — 150 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079095
Marketing start
Listing expires
Other FDA classes
Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68084-708_55052886-2e59-0b6c-e063-6394a90a36ddSPL ID 55052886-2e59-0b6c-e063-6394a90a36ddSPL set ID 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8RxCUI 993503, 993518UNII 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

N468084070825 followed by a unit qualifier and the quantity

Package 68084-0708-25. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablets (SR) 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 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) ]. Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-708

What is NDC 68084-708?
68084-708 is the product NDC for BuPROPion Hydrochloride, Bupropion hydrochloride 150 mg/1 tablet, film coated, extended release, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 68084. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-473970518-4739-00
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-114367046-1143-03
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited59651-51159651-0511-0559651-0511-3059651-0511-90
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited59651-51259651-0512-0559651-0512-3059651-0512-90
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralCoupler LLC67046-127367046-1273-03
Bupropion hydrochlorideBupropion hydrochloride 300 mg/1TabletOralUnit Dose Solutions, Inc.87441-01487441-0014-01
bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-467470518-4674-0070518-4674-0170518-4674-02
Bupropion HydrochlorideBupropion hydrochloride 75 mg/1Tablet, Film coatedOralAmici Pharma, Inc.69292-60169292-0601-01
Bupropion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coatedOralAmici Pharma, Inc.69292-60269292-0602-01
bupropion HydrochlorideBupropion hydrochloride 100 mg/1TabletOralCoupler LLC67046-167267046-1672-03

All 172 BuPROPion Hydrochloride NDCs

Other NDCs under ANDA 079095

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

FDA NDC Directory listings under ANDA 079095
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0591-3542
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-913
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-566
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-952
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0135
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-726
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0591-3540
BuPROPion HydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralAmerican Health Packaging68084-697
Bupropion Hydrochloride SRbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0591-3541

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