Prescription drug · ANDA

Bupropion Hydrochloride XL (bupropion hydrochloride) NDC 82009-051

Bupropion hydrochloride 150 mg/1 · Tablet, Extended release · Oral · Quallent Pharmaceuticals Health LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-051Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0051Add 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
82009-051-0582009005105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-051-05)Marketed from Jul 7, 2023

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 XLSuffix: XL
Generic name (nonproprietary)
bupropion hydrochloride
Active ingredients
Bupropion hydrochloride — 150 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090693
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 82009-051_065bb407-cb85-49d0-ac09-7a379cd2a293SPL ID 065bb407-cb85-49d0-ac09-7a379cd2a293SPL set ID 56df4e22-81ca-48a4-a8e2-038448417355RxCUI 993541, 993557UNII ZG7E5POY8OUPC 0382009052052
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

N482009005105 followed by a unit qualifier and the quantity

Package 82009-0051-05. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride extended-release tablet (XL) is 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 maintenanc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090693

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

FDA NDC Directory listings under ANDA 090693
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralQuallent Pharmaceuticals Health LLC82009-052
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2022
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-098
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-6789
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-3928
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3932
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-4747
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-4749
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralCoupler LLC67046-0699
Bupropion HCL ER (XL)Bupropion hydrochloride 150 mg/1Tablet, Extended releaseOralDirect_Rx61919-558
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7505
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAvPAK50268-133
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralAvPAK50268-134
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7469
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-320
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-319
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-782
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-3559
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-793
Bupropion Hydrochloride XLbupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7602

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