Prescription drug · ANDA
bupropion hydrochloride NDC 16571-862
Bupropion hydrochloride 150 mg/1 · Tablet, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-862-03 | 1657108620316571086203 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-03)Marketed from Aug 1, 2022 | |
| 16571-862-09 | 1657108620916571086209 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-09)Marketed from Aug 1, 2022 | |
| 16571-862-10 | 1657108621016571086210 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-10)Marketed from Aug 1, 2022 | |
| 16571-862-12 | 1657108621216571086212 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-12)Marketed from Jun 3, 2024 | |
| 16571-862-50 | 1657108625016571086250 | 500 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
N416571086203followed by a unit qualifier and the quantityPackage 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.
Related NDCs: other bupropion hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4739 | 70518-4739-00 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1143 | 67046-1143-03 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-511 | 59651-0511-0559651-0511-3059651-0511-90 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-512 | 59651-0512-0559651-0512-3059651-0512-90 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 | 67046-1273-03 |
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-014 | 87441-0014-01 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 | 70518-4674-0070518-4674-0170518-4674-02 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-601 | 69292-0601-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-602 | 69292-0602-01 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1672 | 67046-1672-03 |
Other NDCs under ANDA 211020
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8504 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8505 |
| bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-863 |
| bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4343 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3153 |