Bupropion hydrochloride (XL)
- Product NDC
- 0527-2415
- 11-digit product format
- 005272415
- Labeler code
- 0527
- Product ID
- 0527-2415_5e3c0247-0f79-454e-b14d-1e7dfd1a765e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lannett Company Inc.
- Application
- ANDA208652
- Marketing category
- ANDA
- Marketing start
- 2018-01-08
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 150 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 (XL)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 150 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 |
|---|
| 0527-2415-32 | Bupropion hydrochloride (XL) | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 6 |
| 0527-2415-41 | Bupropion hydrochloride (XL) | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 6 |
| 0527-2415-43 | Bupropion hydrochloride (XL) | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 6 |
| 0527-2415-46 | Bupropion hydrochloride (XL) | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-2415 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241011_15c4e95a-d203-4caf-b6c7-44792355cb76.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 |
|---|
| 0527-2415-32 | 00527241532 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-32) | 2022-01-31 | 0000-00-00 | No | No | Current |
| 0527-2415-41 | 00527241541 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-41) | 2022-01-31 | 0000-00-00 | No | No | Current |
| 0527-2415-43 | 00527241543 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-43) | 2022-01-31 | 0000-00-00 | No | No | Current |
| 0527-2415-46 | 00527241546 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2415-46) | 2022-01-31 | 0000-00-00 | No | No | Current |