Bupropion Hydrochloride
- Product NDC
- 70518-3790
- 11-digit product format
- 705183790
- Labeler code
- 70518
- Product ID
- 70518-3790_4f8307d2-3ea9-ba2d-e063-6394a90a3a82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207479
- Marketing category
- ANDA
- Marketing start
- 2023-07-13
- 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 |
|---|
| 70518-3790-0 | Bupropion Hydrochloride(XL) | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
| 70518-3790-1 | Bupropion Hydrochloride(XL) | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
| 70518-3790-2 | Bupropion Hydrochloride(XL) | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
| 70518-3790-3 | Bupropion Hydrochloride(XL) | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3790 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] | 3 | Current NDC, 4 package rows | 20240608_4cc3327b-92c5-4667-ae16-3e95eafcf4d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3790-0 | 70518379000 | 30 in 1 BLISTER PACK | | | | Historical |
| 70518-3790-1 | 70518379001 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3790-1) | 2024-06-07 | No | No | Current |
| 70518-3790-2 | 70518379002 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-3790-2) | 2026-03-20 | No | No | Current |
| 70518-3790-3 | 70518379003 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3790-3) | 2026-04-15 | No | No | Current |