Bupropion Hydrochloride
- Product NDC
- 53002-2508
- 11-digit product format
- 530022508
- Labeler code
- 53002
- Product ID
- 53002-2508_8260cb49-d827-4c7d-83d7-890d425204b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077285
- Marketing category
- ANDA
- Marketing start
- 2015-02-17
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2508-3 | Bupropion Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2508 | BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_1b4b326e-64a2-4e1c-b16c-9190f4be4bb9.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 |
|---|
| 53002-2508-3 | 53002250803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-2508-3) | 2021-01-01 | 0000-00-00 | No | No | Current |