Aplenzin
- Product NDC
- 0187-5812
- 11-digit product format
- 001875812
- Labeler code
- 0187
- Product ID
- 0187-5812_45372e42-065d-4d87-89af-d5dcf09c29fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA022108
- Marketing category
- NDA
- Marketing start
- 2008-04-23
- Substance
- BUPROPION HYDROBROMIDE
- Active strength
- 522 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aplenzin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROBROMIDE | 522 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E70G3G5863 |
| Rxcui | 993550, 993552, 993567, 993569, 993681, 993683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-5812-07 | Aplenzin | 7 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 7 | | 27 |
| 0187-5812-30 | Aplenzin | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPROPION HYDROBROMIDE | ACTIVE INGREDIENT | E70G3G5863 | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-5812 | APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC] | 21 | Current NDC, Legacy NDC, 2 package rows | 20240802_6494d2d9-0ce4-4126-b1c7-49684395942b.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 |
|---|
| 0187-5812-07 | 00187581207 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5812-07) | 2008-04-23 | 0000-00-00 | No | No | Current |
| 0187-5812-30 | 00187581230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5812-30) | 2008-04-23 | 0000-00-00 | No | No | Current |