Prescription drug · ANDA

Bupropion Hydrochloride NDC 16729-444

Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Accord Healthcare Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16729-444Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0444Add 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
16729-444-101672904441030 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10)Marketed from Mar 25, 2019
16729-444-1616729044416500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16)Marketed from Mar 25, 2019

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, Extended release
Route
Oral
Labeler
Accord Healthcare Inc.NDC labeler code 16729
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210497
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 16729-444_4092a3ea-403d-7a91-e063-6394a90a8ddfSPL ID 4092a3ea-403d-7a91-e063-6394a90a8ddfSPL set ID 34686e9d-c106-4276-8b47-7460cca8860eRxCUI 993541, 993557UNII ZG7E5POY8OUPC 0316729444101, 0316729443104
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

N416729044410 followed by a unit qualifier and the quantity

Package 16729-0444-10. 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 (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 maintena…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-444

What is NDC 16729-444?
16729-444 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Accord Healthcare Inc.. 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?
Accord Healthcare Inc., NDC labeler code 16729. 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?
177 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.70518-467470518-4674-0070518-4674-01
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 178 Bupropion Hydrochloride NDCs

Other NDCs under ANDA 210497

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

FDA NDC Directory listings under ANDA 210497
ProductStrengthForm · routeLabelerProduct NDC
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1214
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralProficient Rx LP71205-504
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7786
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5163
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0461
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5245
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7992
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-301
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralDIRECT RX72189-124
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0300
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-519
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-520
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralDIRECT RX72189-134
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1044
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAccord Healthcare Inc.16729-443
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2458
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralProficient Rx LP71205-465

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