Prescription drug · ANDA
Bupropion Hydrochloride NDC 71335-0013
Bupropion hydrochloride 75 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0013-1 | 71335001301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0013-1)Marketed from Mar 8, 2018 | |
| 71335-0013-2 | 71335001302 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0013-2)Marketed from Feb 21, 2018 | |
| 71335-0013-3 | 71335001303 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0013-3)Marketed from Jul 9, 2024 | |
| 71335-0013-4 | 71335001304 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-0013-4)Marketed from Jul 9, 2024 | |
| 71335-0013-5 | 71335001305 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-0013-5)Marketed from Jul 9, 2024 | |
| 71335-0013-6 | 71335001306 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0013-6)Marketed from Jul 9, 2024 | |
| 71335-0013-7 | 71335001307 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0013-7)Marketed from Jul 9, 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 — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076143
- 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 71335-0013_c9822446-5f21-4d08-983a-226b3557f18dSPL ID c9822446-5f21-4d08-983a-226b3557f18dSPL set ID 1d722dc2-7909-454e-b989-095677079044RxCUI 993691UNII 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
N471335001301followed by a unit qualifier and the quantityPackage 71335-0013-01. 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 tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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 )]. Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076143
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, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7988 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-774 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6636 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-123 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-127 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8180 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4152 |
| Bupropion HCL | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-457 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2256 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-781 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-070 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-164 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-746 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-747 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-143 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-142 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0872 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-880 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1869 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-308 |
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