NDC codes

FDA NDC Directory
Product NDC (as listed)47335-736Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0736Add 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
47335-736-084733507360847335073608100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-08)Marketed from Mar 1, 2020
47335-736-134733507361347335073613500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-13)Marketed from Mar 1, 2020
47335-736-86473350736864733507368660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-86)Marketed from Mar 1, 2020
47335-736-884733507368847335073688100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-88)Marketed from Mar 1, 2020

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, Film coated, Extended release
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078866
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 47335-736_b8e6ae63-c5d7-4481-b7b0-17e135670515SPL ID b8e6ae63-c5d7-4481-b7b0-17e135670515SPL set ID 29848192-7de3-4c0d-a822-1268dcf128b0RxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0347335738865, 0347335737868
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

N447335073608 followed by a unit qualifier and the quantity

Package 47335-0736-08. 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, USP (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 hydrochloride extended-release tablets, USP (SR) 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 is an am…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-736

What is NDC 47335-736?
47335-736 is the product NDC for Bupropion hydrochloride, Bupropion hydrochloride 100 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 078866

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

FDA NDC Directory listings under ANDA 078866
ProductStrengthForm · routeLabelerProduct NDC
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.47335-737
Bupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.47335-738
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-052
Bupropion hydrochlorideBupropion hydrochloride 100 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-176
Bupropion hydrochlorideBupropion hydrochloride 200 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-178

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