Prescription drug · ANDA
bupropion hydrochloride NDC 70518-4343
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4343-0 | 70518434300 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4343-0)Marketed from May 19, 2025 |
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
- REMEDYREPACK INC.
- 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 70518-4343_3d84aca4-4ce7-7ecc-e063-6394a90a0360SPL ID 3d84aca4-4ce7-7ecc-e063-6394a90a0360SPL set ID d087222e-c5e9-4c48-b27f-e2e2944379c8RxCUI 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
N470518434300followed by a unit qualifier and the quantityPackage 70518-4343-00. 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.
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 300 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8505 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3153 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-862 |
| bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-863 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8504 |