bupropion hydrochloride
- Product NDC
- 0904-7099
- 11-digit product format
- 009047099
- Labeler code
- 0904
- Product ID
- 0904-7099_bc353d98-bf85-4efb-995a-bb3dfd28825c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA202304
- Marketing category
- ANDA
- Marketing start
- 2026-01-21
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- bupropion hydrochloride
- Brand name suffix
- SR
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993503, 993518 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7099-61 | bupropion hydrochlorideSR | 100 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 100 | | 3 |
| 0904-7099-61 | bupropion hydrochlorideSR | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7099-61 | 00904709961 | 100 BLISTER PACK in 1 CARTON (0904-7099-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2026-01-21 | No | No | Historical |