Prescription drug · ANDA
bupropion (Bupropion hydrochloride) NDC 71335-0801
Bupropion hydrochloride 200 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0801-1 | 7133508010171335080101 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-1)Marketed from May 1, 2018 | |
| 71335-0801-2 | 7133508010271335080102 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-2)Marketed from Aug 9, 2024 | |
| 71335-0801-3 | 7133508010371335080103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-3)Marketed from Aug 9, 2024 | |
| 71335-0801-4 | 7133508010471335080104 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-4)Marketed from Aug 9, 2024 | |
| 71335-0801-5 | 7133508010571335080105 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-5)Marketed from Aug 9, 2024 | |
| 71335-0801-6 | 7133508010671335080106 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-6)Marketed from Aug 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
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202304
- 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 71335-0801_645edeba-9a73-4d0a-ac84-2de98e89b760SPL ID 645edeba-9a73-4d0a-ac84-2de98e89b760SPL set ID 7ded4fa6-e637-4d59-a1b1-286854d4fe3aRxCUI 993536UNII 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
N471335080101followed by a unit qualifier and the quantityPackage 71335-0801-01. 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 (SR) tablets 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 (SR) tablets 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.
About NDC 71335-0801
- What is NDC 71335-0801?
- 71335-0801 is the product NDC for bupropion (bupropion hydrochloride), Bupropion hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- bupropion (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for bupropion?
- 7 other product NDCs are listed under this name. See all bupropion NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other bupropion products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-357 | 51655-0357-2651655-0357-52 |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-836 | 65841-0836-0565841-0836-0665841-0836-10+1 more |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-353 | 68382-0353-0568382-0353-0668382-0353-10+1 more |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-565 | 71205-0565-3071205-0565-6071205-0565-90 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-521 | 63187-0521-3063187-0521-6063187-0521-90 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-780 | 65841-0780-0565841-0780-0665841-0780-10+1 more |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-354 | 68382-0354-0568382-0354-0668382-0354-10+1 more |
Other NDCs under ANDA 202304
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 100 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7099 |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-565 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-288 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-289 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-290 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-057 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7465 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-0183 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4591 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | QPharma Inc | 42708-205 |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-357 |