Prescription drug · ANDA
Bupropion HCL ER(SR) NDC 72189-676
Bupropion hydrochloride 100 mg/1 · Tablet, Extended release · Oral · DriectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-676-30 | 7218906763072189067630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-676-30)Marketed from Apr 30, 2026 | |
| 72189-676-60 | 7218906766072189067660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-676-60)Marketed from Apr 30, 2026 |
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 HCL ER(SR)
- Generic name (nonproprietary)
- bupropion hcl er(sr)
- Active ingredients
- Bupropion hydrochloride — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- DriectRxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216800
- 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 72189-676_5a5c4d58-a185-a95d-e063-6394a90a0b7eSPL ID 5a5c4d58-a185-a95d-e063-6394a90a0b7eSPL set ID 50afb442-e7c6-d28c-e063-6294a90a2b7eRxCUI 993503UNII 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
N472189067630followed by a unit qualifier and the quantityPackage 72189-0676-30. 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 .
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 tablets (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)].
Excerpt only. Read the full label for complete information.
About NDC 72189-676
- What is NDC 72189-676?
- 72189-676 is the product NDC for Bupropion HCL ER(SR), Bupropion hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by DriectRx. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupropion HCL ER(SR).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- DriectRx, NDC labeler code 72189. 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 HCL ER(SR)?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 216800
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, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8601 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8602 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-066 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-067 |
| Bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-068 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7349 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7422 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7423 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1572 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8769 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4081 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4093 |
| Bupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2400 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2457 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2496 |
| Bupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2649 |