Bupropion Hydrochloride
- Product NDC
- 70518-4551
- 11-digit product format
- 705184551
- Labeler code
- 70518
- Product ID
- 70518-4551_48e5c091-b7e5-2541-e063-6394a90ab618
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207224
- Marketing category
- ANDA
- Marketing start
- 2026-01-20
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 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
- XL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993557 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4551-0 | Bupropion HydrochlorideXL | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4551-0 | 70518455100 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4551-0) | 2026-01-20 | No | No | Historical |