Prescription drug · ANDA
Bupropion Hydrochloride (SR) (Bupropion hydrochloride) NDC 50228-338
Bupropion hydrochloride 150 mg/1 · Tablet, Film coated, Extended release · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-338-11 | 5022803381150228033811 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-11)Marketed from May 1, 2019 | |
| 50228-338-31 | 5022803383150228033831 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-31)Marketed from May 1, 2019 | |
| 50228-338-61 | 5022803386150228033861 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-61)Marketed from May 1, 2019 |
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 (SR)Suffix: (SR)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206122
- 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 50228-338_d9b7b0d0-71db-578b-e053-2a95a90a8514SPL ID d9b7b0d0-71db-578b-e053-2a95a90a8514SPL set ID 2bb61b34-653a-43b4-9682-705d5b82d18eRxCUI 1801289UNII ZG7E5POY8OUPC 0350228338110, 0350228338615, 0350228338318
- 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
N450228033811followed by a unit qualifier and the quantityPackage 50228-0338-11. 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, USP (SR) are indicated as an aid to smoking cessation treatment. Bupropion hydrochloride extended-release tablets, USP (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50228-338
- What is NDC 50228-338?
- 50228-338 is the product NDC for Bupropion Hydrochloride (SR) (bupropion hydrochloride), Bupropion hydrochloride 150 mg/1 tablet, film coated, extended release, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupropion Hydrochloride (SR) (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 Hydrochloride (SR)?
- 74 other product NDCs are listed under this name. See all Bupropion Hydrochloride (SR) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bupropion Hydrochloride (SR) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-443 | 42806-0443-0142806-0443-60 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-441 | 42806-0441-0142806-0441-0542806-0441-60 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-442 | 42806-0442-0142806-0442-0542806-0442-60 |
| Bupropion Hydrochloride (SR)bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-526 | 33342-0526-0933342-0526-1133342-0526-15 |
| Bupropion Hydrochloride (SR)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-527 | 33342-0527-1033342-0527-1133342-0527-15 |
| Bupropion Hydrochloride (SR)bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-528 | 33342-0528-0933342-0528-11 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4591 | 70518-4591-00 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7099 | 00904-7099-61 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-0183 | 55154-0183-00 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7465 | 00904-7465-61 |
Other NDCs under ANDA 206122
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 (SR)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc | 43598-863 |
| Bupropion Hydrochloride (SR)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5101 |