Bupropion Hydrochloride
- Product NDC
- 70436-060
- 11-digit product format
- 704360060
- Labeler code
- 70436
- Product ID
- 70436-060_1b0de43f-05c2-aed6-e063-6394a90ac5df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA211347
- Marketing category
- ANDA
- Marketing start
- 2020-11-02
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 200 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
- SR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993503, 993518, 993536 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-060-01 | Bupropion HydrochlorideSR | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 17 |
| 70436-060-02 | Bupropion HydrochlorideSR | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 17 |
| 70436-060-05 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-060 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] | 17 | Current NDC, Legacy NDC, 3 package rows | 20240617_7c4313fa-bb29-dd50-e053-2991aa0a3005.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 |
|---|
| 70436-060-01 | 70436006001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-060-01) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 70436-060-02 | 70436006002 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-060-02) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 70436-060-05 | 70436006005 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-060-05) | 2020-11-02 | 0000-00-00 | No | No | Current |