Prescription drug · ANDA
Bupropion Hydrochloride (XL) (bupropion hydrochloride) NDC 77771-145
Bupropion hydrochloride 300 mg/1 · Tablet, Film coated, Extended release · Oral · RADHA PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-145-05 | 77771014505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-145-05)Marketed from Oct 26, 2022 | |
| 77771-145-30 | 77771014530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-145-30)Marketed from Oct 26, 2022 | |
| 77771-145-90 | 77771014590 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-145-90)Marketed from Oct 26, 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 (XL)Suffix: (XL)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- RADHA PHARMACEUTICALS, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207479
- 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 77771-145_3bf617e4-22ef-4237-b80b-24c4c1b1bfdaSPL ID 3bf617e4-22ef-4237-b80b-24c4c1b1bfdaSPL set ID 16a788ff-8bd5-4f70-a3fd-a89db019e435RxCUI 993541, 993557UNII ZG7E5POY8OUPC 0377771145903, 0377771145057, 0377771145309, 0377771144906, 0377771144302, 0377771144050
- 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
N477771014505followed by a unit qualifier and the quantityPackage 77771-0145-05. 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 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 207479
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 (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | RADHA PHARMACEUTICALS, INC. | 77771-144 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2312 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4172 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8474 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8475 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8476 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-3790 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals,Inc. | 50228-144 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals,Inc. | 50228-145 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3927 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0539 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7711 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7712 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7335 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7334 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-3963 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 82868-097 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1527 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1526 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Dr Reddys Laboratories Inc | 43598-655 |
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