Prescription drug · ANDA
Bupropion Hydrochloride (SR) (Bupropion hydrochloride) NDC 69097-878
Bupropion hydrochloride 150 mg/1 · Tablet, Extended release · Oral · Cipla USA Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-878-02 | 69097087802 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-878-02)Marketed from Jul 25, 2016 | |
| 69097-878-03 | 69097087803 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-878-03)Marketed from Jul 25, 2016 | |
| 69097-878-07 | 69097087807 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-878-07)Marketed from Jul 25, 2016 | |
| 69097-878-12 | 69097087812 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-878-12)Marketed from Jul 25, 2016 |
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)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Cipla USA Inc.,NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206674
- 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 69097-878_a9b85841-5a69-4df1-a22d-3d4cf174e9a6SPL ID a9b85841-5a69-4df1-a22d-3d4cf174e9a6SPL set ID 9d2c209b-248e-4e26-9cde-fe0abe4428c1RxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0369097879037, 0369097878030, 0369097877033
- 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
N469097087802followed by a unit qualifier and the quantityPackage 69097-0878-02. 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 tablet (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-releas…
Excerpt only. Read the full label for complete information.
About NDC 69097-878
- What is NDC 69097-878?
- 69097-878 is the product NDC for Bupropion Hydrochloride (SR) (bupropion hydrochloride), Bupropion hydrochloride 150 mg/1 tablet, extended release, listed with the FDA by Cipla USA Inc.,. It has 4 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?
- Cipla USA Inc.,, NDC labeler code 69097. 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)?
- 70 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 (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 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4056 | 70518-4056-01 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 82868-019 | 82868-0019-3082868-0019-6082868-0019-90+1 more |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Epic Pharma, LLC | 42806-426 | 42806-0426-0142806-0426-0542806-0426-60 |
Other NDCs under ANDA 206674
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 100 mg/1 | Tablet, Extended releaseOral | Cipla USA Inc., | 69097-877 |
| Bupropion Hydrochloride (SR)bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Cipla USA Inc., | 69097-879 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-744 |