NDC 47335-736 – Bupropion hydrochloride
Bupropion Hydrochloride 100 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC47335-736
Product details
- Brand name
- Bupropion hydrochloride
- Generic name
- Bupropion hydrochloride
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA078866
- Marketed since
- March 1, 2020
- Listing expires
- December 31, 2026
- Pharmacologic class
- Aminoketone
Active ingredients
- Bupropion Hydrochloride 100 mg/1
Uses, dosage, side effects and warnings for Bupropion hydrochloride →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 47335-736-08 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-08) | Mar 1, 2020 |
| 47335-736-13 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-13) | Mar 1, 2020 |
| 47335-736-86 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-86) | Mar 1, 2020 |
| 47335-736-88 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-88) | Mar 1, 2020 |
Recalls mentioning this NDC
- D-0137-2024 Dec 13, 2023 · Class III
Failed Dissolution Specifications - D-0044-2024 Oct 25, 2023 · Class III
Failed Dissolution Specifications - D-0761-2023 May 31, 2023 · Class II
Failed Dissolution Specifications; during stability testing - D-0858-2022 May 18, 2022 · Class III
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the… - D-0857-2022 May 18, 2022 · Class III
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the… - D-0445-2017 Feb 1, 2017 · Class III
Failed Dissolution Specifications; 18 month stability time point - D-0007-2017 Oct 12, 2016 · Class III
Failed Dissolution Specifications - D-1446-2016 Jul 27, 2016 · Class III
Failed Dissolution Specifications - D-1345-2015 Aug 26, 2015 · Class III
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
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