bupropion hydrochloride
- Product NDC
- 16571-863
- 11-digit product format
- 165710863
- Labeler code
- 16571
- Product ID
- 16571-863_fe42636a-ae04-43be-b032-8973bbdde7d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA211020
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- 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
- 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 | 993541, 993557 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-863-03 | bupropion hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 16571-863-09 | bupropion hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
| 16571-863-10 | bupropion hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 4 |
| 16571-863-50 | bupropion hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-863 | BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241114_e4f4d3fa-ddf6-4125-8486-8157efc095c1.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 |
|---|
| 16571-863-03 | 16571086303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-03) | 2022-08-01 | 0000-00-00 | No | No | Current |
| 16571-863-09 | 16571086309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-09) | 2022-08-01 | 0000-00-00 | No | No | Current |
| 16571-863-10 | 16571086310 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-10) | 2022-08-01 | 0000-00-00 | No | No | Current |
| 16571-863-50 | 16571086350 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-50) | 2022-08-01 | 0000-00-00 | No | No | Current |