NDC codes

FDA NDC Directory
Product NDC (as listed)16571-862Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0862Add 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
16571-862-03165710862031657108620330 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-03)Marketed from Aug 1, 2022
16571-862-09165710862091657108620990 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-09)Marketed from Aug 1, 2022
16571-862-1016571086210165710862101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-10)Marketed from Aug 1, 2022
16571-862-121657108621216571086212120 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-12)Marketed from Jun 3, 2024
16571-862-501657108625016571086250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-50)Marketed from Aug 1, 2022

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, Extended release
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211020
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 16571-862_6aa98609-238e-480b-bbc8-879b379edd24SPL ID 6aa98609-238e-480b-bbc8-879b379edd24
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

N416571086203 followed by a unit qualifier and the quantity

Package 16571-0862-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 16571-862

What is NDC 16571-862?
16571-862 is the product NDC for bupropion hydrochloride, Bupropion hydrochloride 150 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 5 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?
Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 211020

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

FDA NDC Directory listings under ANDA 211020
ProductStrengthForm · routeLabelerProduct NDC
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8504
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8505
bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralRising Pharma Holdings, Inc.16571-863
bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4343
bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4674
bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-3153

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