Bupropion Hydrochloride
- Product NDC
- 53217-252
- 11-digit product format
- 532170252
- Labeler code
- 53217
- Product ID
- 53217-252_31148e02-1a6a-4ac0-81c9-9913d0afe240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA206674
- Marketing category
- ANDA
- Marketing start
- 2016-07-25
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 100 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
- 2019-12-31
- 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 |
|---|
| 53217-252-30 | Bupropion Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 53217-252-60 | Bupropion Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
| 53217-252-90 | Bupropion Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-252 | BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20161110_538a0be1-8eab-4f8b-b967-30b9afdd7655.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-252-30 | 53217025230 | 30 in 1 BOTTLE | Historical |
| 53217-252-60 | 53217025260 | 60 in 1 BOTTLE | Historical |
| 53217-252-90 | 53217025290 | 90 in 1 BOTTLE | Historical |