Prescription drug · ANDA

Bupropion Hydrochloride NDC 71335-1214

Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1214Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1214Add 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
71335-1214-17133512140130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-1)Marketed from May 3, 2019
71335-1214-27133512140260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-2)Marketed from Apr 22, 2021
71335-1214-37133512140390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-3)Marketed from Jun 10, 2019
71335-1214-471335121404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-4)Marketed from May 29, 2019
71335-1214-5713351214058 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-5)Marketed from Aug 9, 2024
71335-1214-671335121406180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-6)Marketed from Aug 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1214_6c94f0d8-1b25-4963-9368-2a632fa8348cSPL ID 6c94f0d8-1b25-4963-9368-2a632fa8348cSPL set ID 82bcdd72-9146-4c8d-a8aa-f92015864605RxCUI 993557UNII 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

N471335121401 followed by a unit qualifier and the quantity

Package 71335-1214-01. 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 71335-1214

What is NDC 71335-1214?
71335-1214 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 150 mg/1Tablet, Extended releaseOralAccord Healthcare Inc.16729-443
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralAccord Healthcare Inc.16729-444
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5163
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5245
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 releaseOralPreferred Pharmaceuticals Inc.68788-7786
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7992
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2458
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralProficient Rx LP71205-465
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralProficient Rx LP71205-504
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1044
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralDIRECT RX72189-124
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralDIRECT RX72189-134
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-301
Bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0300
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0461

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