BuPROPion Hydrochloride
- Product NDC
- 43353-546
- 11-digit product format
- 433530546
- Labeler code
- 43353
- Product ID
- 43353-546_83ef2126-1308-4f4c-a917-a360c7e9f3f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BuPROPion Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA079095
- Marketing category
- ANDA
- Marketing start
- 2009-07-02
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 150 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 |
|---|
| 43353-546-30 | BuPROPion Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 43353-546-60 | BuPROPion Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
| 43353-546-80 | BuPROPion Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 180 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPROPION HYDROCHLORIDE | ACTIVE INGREDIENT | ZG7E5POY8O | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-546 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 3 package rows | 20140611_3b41a8f8-34f4-4a38-9013-9cefafd6009c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-546-30 | 43353054630 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 43353-546-60 | 43353054660 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 43353-546-80 | 43353054680 | 180 in 1 BOTTLE, PLASTIC | Historical |