Bupropion Hydrochloride
- Product NDC
- 63187-566
- 11-digit product format
- 631870566
- Labeler code
- 63187
- Product ID
- 63187-566_c925c162-1843-4844-81d6-781b8f6d5d30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA079095
- Marketing category
- ANDA
- Marketing start
- 2009-07-02
- 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
- Brand name suffix
- SR
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-566-30 | Bupropion HydrochlorideSR | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
| 63187-566-60 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 3 |
| 63187-566-90 | Bupropion HydrochlorideSR | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPROPION HYDROCHLORIDE | ACTIVE INGREDIENT | ZG7E5POY8O | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-566 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20200218_a165869a-9bc4-4987-babe-a77fad78c38f.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 |
|---|
| 63187-566-30 | 63187056630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-566-60 | 63187056660 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-566-90 | 63187056690 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-90) | 2018-12-01 | 0000-00-00 | No | No | Current |