Bupropion Hydrochloride
- Product NDC
- 70436-011
- 11-digit product format
- 704360011
- Labeler code
- 70436
- Product ID
- 70436-011_1b0d6505-54e6-a28f-e063-6294a90aae71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA210015
- Marketing category
- ANDA
- Marketing start
- 2018-12-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Brand name suffix
- XL
- 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 | 993541, 993557 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-011-02 | Bupropion HydrochlorideXL | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 14 |
| 70436-011-04 | Bupropion HydrochlorideXL | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 14 |
| 70436-011-06 | Bupropion HydrochlorideXL | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-011 | BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240617_06d4d890-11ed-4f31-8778-c73432e3ea69.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 |
|---|
| 70436-011-02 | 70436001102 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 70436-011-04 | 70436001104 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 70436-011-06 | 70436001106 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06) | 2018-12-01 | 0000-00-00 | No | No | Current |