bupropion
- Product NDC
- 71335-0801
- 11-digit product format
- 713350801
- Labeler code
- 71335
- Product ID
- 71335-0801_645edeba-9a73-4d0a-ac84-2de98e89b760
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202304
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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
- 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 | 993536 |
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 |
|---|
| 71335-0801-1 | bupropion | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 103 |
| 71335-0801-2 | bupropion | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 103 |
| 71335-0801-3 | bupropion | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 103 |
| 71335-0801-4 | bupropion | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 103 |
| 71335-0801-5 | bupropion | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 103 |
| 71335-0801-6 | bupropion | 28 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 28 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0801 | BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 6 package rows | 20240822_7ded4fa6-e637-4d59-a1b1-286854d4fe3a.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 |
|---|
| 71335-0801-1 | 71335080101 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-1) | 2018-05-01 | 0000-00-00 | No | No | Current |
| 71335-0801-2 | 71335080102 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-2) | 2024-08-09 | 0000-00-00 | No | No | Current |
| 71335-0801-3 | 71335080103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-3) | 2024-08-09 | 0000-00-00 | No | No | Current |
| 71335-0801-4 | 71335080104 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-4) | 2024-08-09 | 0000-00-00 | No | No | Current |
| 71335-0801-5 | 71335080105 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-5) | 2024-08-09 | 0000-00-00 | No | No | Current |
| 71335-0801-6 | 71335080106 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-6) | 2024-08-09 | 0000-00-00 | No | No | Current |