Bupropion hydrochloride
- Product NDC
- 47335-738
- 11-digit product format
- 473350738
- Labeler code
- 47335
- Product ID
- 47335-738_b8e6ae63-c5d7-4481-b7b0-17e135670515
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078866
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- 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 hydrochloride
- 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 | 993503, 993518, 993536 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-738-08 | Bupropion hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 16 |
| 47335-738-13 | Bupropion hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 16 |
| 47335-738-86 | Bupropion hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 16 |
| 47335-738-88 | Bupropion hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 16 |
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 [SUN PHARMA GLOBAL FZE] | 7 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| SACCHARIN | INACTIVE INGREDIENT | FST467XS7D | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| BUPROPION HYDROCHLORIDE | ACTIVE INGREDIENT | ZG7E5POY8O | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| SACCHARIN | INACTIVE INGREDIENT | FST467XS7D | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-738 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20241210_29848192-7de3-4c0d-a822-1268dcf128b0.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 |
|---|
| 47335-738-08 | 47335073808 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 47335-738-13 | 47335073813 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 47335-738-86 | 47335073886 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 47335-738-88 | 47335073888 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88) | 2020-03-01 | 0000-00-00 | No | No | Current |