Bupropion Hydrochloride
- Product NDC
- 55648-102
- 11-digit product format
- 556480102
- Labeler code
- 55648
- Product ID
- 55648-102_e0163d85-d240-4908-8b50-c7f76ba704e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- ANDA202189
- Marketing category
- ANDA
- Marketing start
- 2012-11-21
- 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 |
|---|
| 55648-102-01 | Bupropion Hydrochloride(XL) | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
| 55648-102-02 | Bupropion Hydrochloride(XL) | 90 in 1 BOTTLE | 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 (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| AMMONIUM CHLORIDE | INACTIVE INGREDIENT | 01Q9PC255D | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-102 | BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED] | 3 | Legacy NDC, 2 package rows | 20150414_653cf774-2996-4bc2-b88f-8b4b0eb2e08c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-102-01 | 55648010201 | 30 in 1 BOTTLE | Historical |
| 55648-102-02 | 55648010202 | 90 in 1 BOTTLE | Historical |