Bupropion Hydrochloride
- Product NDC
- 53002-1345
- 11-digit product format
- 530021345
- Labeler code
- 53002
- Product ID
- 53002-1345_8504c79f-9030-45b5-8a1c-89d6addab21b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4eceb285-f3c7-4092-a21a-4c9f3169f20c | Product name | 5 | 20260220 |
| 548ba7fd-fd0c-4a21-b2b0-d01bf93143b8 | Product name | 3 | 20240209 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| b8ee525f-67fb-39fb-91da-7e47ac54581d | Product name | 5 | 20200611 |
| 98e65af1-f5d0-75d5-c930-f8a4ce4c3284 | Product name | 9 | 20190211 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 0916dcfb-331f-89b1-8eac-6f7dc76d82da | Product name | 1 | 20140508 |
| d7fc3d53-5a6c-de82-2808-1780f175f17e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1345-0 | Bupropion HydrochlorideSR | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 5 | |
| 53002-1345-3 | Bupropion HydrochlorideSR | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 5 | |
| 53002-1345-6 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1345 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_53f55247-ba8c-4960-9981-05ad1b501643.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 53f55247-ba8c-4960-9981-05ad1b501643 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53002-1345-0 | 53002134500 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-1345-0) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1345-3 | 53002134503 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-1345-3) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1345-6 | 53002134506 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-1345-6) | 2017-09-01 | 0000-00-00 | No | No | Current |