Bupropion Hydrochloride
- Product NDC
- 63187-819
- 11-digit product format
- 631870819
- Labeler code
- 63187
- Product ID
- 63187-819_a35c75a3-e0fd-4031-8f4c-b350cac13875
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077285
- Marketing category
- ANDA
- Marketing start
- 2015-02-17
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 63187-819-30 | Bupropion Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 63187-819-60 | Bupropion Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 5 |
| 63187-819-78 | Bupropion Hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 5 |
| 63187-819-90 | Bupropion Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-819 | BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20221005_9e2d9c1e-a1de-491d-8f64-34ae60419611.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-819-30 | 63187081930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-30) | 2017-02-01 | 0000-00-00 | No | No | Current |
| 63187-819-60 | 63187081960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-60) | 2017-02-01 | 0000-00-00 | No | No | Current |
| 63187-819-78 | 63187081978 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-78) | 2017-02-01 | 0000-00-00 | No | No | Current |
| 63187-819-90 | 63187081990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-90) | 2017-02-01 | 0000-00-00 | No | No | Current |