Prescription drug · ANDA
BuPROPion Hydrochloride NDC 68084-697
Bupropion hydrochloride 100 mg/1 · Tablet, Film coated, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-697-01 | 6808406970168084069701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-697-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-697-11)Marketed from Apr 2, 2015 |
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
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079095
- 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 68084-697_55052886-2e59-0b6c-e063-6394a90a36ddSPL ID 55052886-2e59-0b6c-e063-6394a90a36ddSPL set ID 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8RxCUI 993503, 993518UNII 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
N468084069701followed by a unit qualifier and the quantityPackage 68084-0697-01. 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 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 tablets (SR) are an aminoketone antidepressa…
Excerpt only. Read the full label for complete information.
About NDC 68084-697
- What is NDC 68084-697?
- 68084-697 is the product NDC for BuPROPion Hydrochloride, Bupropion hydrochloride 100 mg/1 tablet, film coated, extended release, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BuPROPion Hydrochloride.
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. 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?
- 171 other product NDCs are listed under this name. See all BuPROPion Hydrochloride 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 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 | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4739 | 70518-4739-00 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1143 | 67046-1143-03 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-511 | 59651-0511-0559651-0511-3059651-0511-90 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-512 | 59651-0512-0559651-0512-3059651-0512-90 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 | 67046-1273-03 |
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-014 | 87441-0014-01 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 | 70518-4674-0070518-4674-0170518-4674-02 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-601 | 69292-0601-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-602 | 69292-0602-01 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1672 | 67046-1672-03 |
Other NDCs under ANDA 079095
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 200 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3542 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-913 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-566 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-952 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0135 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-726 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3540 |
| BuPROPion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-708 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3541 |