Bupropion Hydrochloride
- Product NDC
- 0591-3542
- 11-digit product format
- 005913542
- Labeler code
- 0591
- Product ID
- 0591-3542_46100e89-6164-4144-8f8b-761371282a01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion Hydrochloride
- Brand name suffix
- SR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPROPION HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | ZG7E5POY8O |
| Rxcui | 993503, 993518, 993536 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-3542-01 | Bupropion HydrochlorideSR | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 100 | 55 | |
| 0591-3542-05 | Bupropion HydrochlorideSR | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | 55 | |
| 0591-3542-60 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | 55 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3542-60 | EA - Each | 0591-3542 | 178c03f3-848a-43f5-902e-6a927295229e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0591-3542 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 53 | Current NDC, Legacy NDC, 3 package rows | 20250406_cec41945-8d64-4793-8784-4c2b8ec37b0f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | cec41945-8d64-4793-8784-4c2b8ec37b0f | 55 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | a165869a-9bc4-4987-babe-a77fad78c38f | 3 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | a165869a-9bc4-4987-babe-a77fad78c38f | 3 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | a165869a-9bc4-4987-babe-a77fad78c38f | 3 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | 7dc7c367-1d69-7634-e053-2a91aa0a9cb9 | 2 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | 7dc7c367-1d69-7634-e053-2a91aa0a9cb9 | 2 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | 7dc7c367-1d69-7634-e053-2a91aa0a9cb9 | 2 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | cde8d7f2-2116-435b-8bbb-83d50de74bfb | 1 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | cde8d7f2-2116-435b-8bbb-83d50de74bfb | 1 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | cde8d7f2-2116-435b-8bbb-83d50de74bfb | 1 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0591-3542-01 | 00591354201 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-01) | 2009-07-02 | 0000-00-00 | No | No | Current |
| 0591-3542-05 | 00591354205 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-05) | 2009-07-02 | 0000-00-00 | No | No | Current |
| 0591-3542-60 | 00591354260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-60) | 2009-07-02 | 0000-00-00 | No | No | Current |