Bupropion Hydrochloride
- Product NDC
- 10370-102
- 11-digit product format
- 103700102
- Labeler code
- 10370
- Product ID
- 10370-102_a9a1f889-378e-4569-be40-a816d914ec6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA077284
- Marketing category
- ANDA
- Marketing start
- 2007-06-12
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
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 [PAR PHARMACEUTICAL, INC.] | 21 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 21 | |
| BUPROPION HYDROCHLORIDE | ACTIVE INGREDIENT | ZG7E5POY8O | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BUPROPION | ACTIVE MOIETY | 01ZG3TPX31 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10370-102 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.] | 37 | Legacy NDC | 20231208_a5ddc0dc-c176-4705-a9a0-e4ecaf1f5667.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 |
|---|
| 10370-102-03 | 10370010203 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-03) | 2007-06-12 | 0000-00-00 | No | No | Current |
| 10370-102-50 | 10370010250 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-50) | 2007-06-12 | 0000-00-00 | No | No | Current |