Bupropion Hydrochloride
- Product NDC
- 70436-059
- 11-digit product format
- 704360059
- Labeler code
- 70436
- Product ID
- 70436-059_1b0de43f-05c2-aed6-e063-6394a90ac5df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA211347
- Marketing category
- ANDA
- Marketing start
- 2020-11-02
- 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
- 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 |
|---|---|
| BUPROPION HYDROCHLORIDE | 150 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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| b8ee525f-67fb-39fb-91da-7e47ac54581d | Product name | 5 | 20200611 |
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 98e65af1-f5d0-75d5-c930-f8a4ce4c3284 | Product name | 9 | 20190211 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 0916dcfb-331f-89b1-8eac-6f7dc76d82da | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | 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 |
|---|---|---|---|---|---|---|
| 70436-059-01 | Bupropion HydrochlorideSR | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 17 | |
| 70436-059-02 | Bupropion HydrochlorideSR | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 17 | |
| 70436-059-05 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 17 | |
| 70436-059-22 | Bupropion HydrochlorideSR | 250 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 250 | 17 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70436-059 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] | 17 | Current NDC, Legacy NDC, 4 package rows | 20240617_7c4313fa-bb29-dd50-e053-2991aa0a3005.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 0574b84d-075f-410f-a8eb-86901e307ea2 | 106 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 0574b84d-075f-410f-a8eb-86901e307ea2 | 106 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 0574b84d-075f-410f-a8eb-86901e307ea2 | 106 |
| 993503 | buPROPion HCl 100 MG 12HR Extended Release Oral Tablet | PSN | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993536 | buPROPion HCl 200 MG 12HR Extended Release Oral Tablet | PSN | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993503 | 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet | SCD | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993536 | 12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet | SCD | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993503 | bupropion HCl 100 MG 12 HR Extended Release Oral Tablet | SY | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993536 | bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet | SY | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 17 |
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | f2b3939b-a410-6354-e053-2995a90ababb | 3 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | f2b3939b-a410-6354-e053-2995a90ababb | 3 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | f2b3939b-a410-6354-e053-2995a90ababb | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70436-059-01 | 70436005901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-01) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 70436-059-02 | 70436005902 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-02) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 70436-059-05 | 70436005905 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-05) | 2020-11-02 | 0000-00-00 | No | No | Current |
| 70436-059-22 | 70436005922 | 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-22) | 2020-11-02 | 0000-00-00 | No | No | Current |