Prescription drug · ANDA
Bupropion hydrochloride NDC 71335-2496
Bupropion hydrochloride 100 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2496-1 | 71335249601 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-1)Marketed from Sep 16, 2024 | |
| 71335-2496-2 | 71335249602 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-2)Marketed from Sep 16, 2024 | |
| 71335-2496-3 | 71335249603 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-3)Marketed from Sep 16, 2024 | |
| 71335-2496-4 | 71335249604 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-4)Marketed from Sep 16, 2024 | |
| 71335-2496-5 | 71335249605 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-5)Marketed from Sep 16, 2024 | |
| 71335-2496-6 | 71335249606 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2496-6)Marketed from Sep 16, 2024 |
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 — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216800
- 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 71335-2496_2f585b80-562d-4ca7-ac1f-85a87579a6efSPL ID 2f585b80-562d-4ca7-ac1f-85a87579a6efSPL set ID 350336bf-57b1-4d2f-bf25-956bb6023c07RxCUI 993503UNII 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
N471335249601followed by a unit qualifier and the quantityPackage 71335-2496-01. 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) are 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 ta…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216800
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 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7349 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2649 |
| Bupropion HCL ER(SR) | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DriectRx | 72189-676 |
| Bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2400 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7423 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7422 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8601 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8602 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2457 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1572 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4081 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4093 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 |
| Bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-068 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-066 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-067 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8769 |
- openFDA data updated
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