Prescription drug · ANDA
Bupropion Hydrochloride SR (bupropion hydrochloride) NDC 77771-174
Bupropion hydrochloride 100 mg/1 · Tablet, Film coated, Extended release · Oral · Radha Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-174-05 | 77771017405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-05)Marketed from Apr 15, 2021 | |
| 77771-174-60 | 77771017460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-60)Marketed from Apr 15, 2021 |
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 SRSuffix: SR
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 100 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 205794
- 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 77771-174_5a38f43e-ac1b-4cf2-b454-79d08f5dd555SPL ID 5a38f43e-ac1b-4cf2-b454-79d08f5dd555SPL set ID 161637d2-bc9d-4a2b-ad1f-6cc39ffd69ceRxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0377771175054, 0377771174057
- 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
N477771017405followed by a unit qualifier and the quantityPackage 77771-0174-05. 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 (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14 )] . Bupropion hydrochloride extended-release…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205794
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 SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8473 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-3787 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-175 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-174 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc. | 50228-176 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-576 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 82868-019 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-582 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1866 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-7130 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Inc. | 43598-537 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Inc. | 43598-536 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddys Laboratories Inc. | 43598-538 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1529 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-6871 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-6872 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-158 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4056 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7793 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7807 |
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