Quinidine Gluconate
- Product NDC
- 53489-141
- 11-digit product format
- 534890141
- Labeler code
- 53489
- Product ID
- 53489-141_47cec250-341a-4694-a232-93106833a75e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quinidine Gluconate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA089338
- Marketing category
- ANDA
- Marketing start
- 1987-02-10
- Substance
- QUINIDINE GLUCONATE
- Active strength
- 324 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089338-001 | QUINIDINE GLUCONATE | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A089338-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | BX | RS | 1987-02-11 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | BX | RS | 1987-02-11 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1987-02-11 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089338-001 | QUINIDINE GLUCONATE | 324MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1987-02-11 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A089338-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089338-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A089338-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089338-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089338-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089338-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089338-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089338-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089338-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A089338-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089338-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089338-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089338-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A089338-001 | AB | 1 | 8072bd15b7f6… |
| 2022-04-04 05:41 UTC | 2022-04 | A089338-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A089338-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A089338-001 | AB | 1 | 782e0a99824c… |
| 2019-09-15 20:21 UTC | 2019-09 | A089338-001 | BX | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A089338-001 | BX | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089338-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A089338-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A089338-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089338-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089338-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089338-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089338-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A089338-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A089338-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089338-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A089338-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A089338-001 | AB | 1 | e64feba35796… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A089338-001 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quinidine Gluconate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUINIDINE GLUCONATE | 324 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R6875N380F | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 852920 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5023f053-fcc4-4c2c-aa59-9ec198ad185e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 5c89f85a-bde6-5cf8-a351-de14631f6a68 | Product name | 2 | 20220315 |
| 3cea42cf-df28-7a4d-1e04-432ad7cc2928 | Product name | 1 | 20140508 |
| 607c7c15-7bf2-457f-7c66-b7729171afe6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53489-141-01 | Quinidine Gluconate | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | 5 | |
| 53489-141-03 | Quinidine Gluconate | 250 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 250 | 5 | |
| 53489-141-05 | Quinidine Gluconate | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | 5 | |
| 53489-141-06 | Quinidine Gluconate | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | 5 | |
| 53489-141-07 | Quinidine Gluconate | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | 5 | |
| 53489-141-10 | Quinidine Gluconate | 1000 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 1000 | 5 | |
| 53489-141-90 | Quinidine Gluconate | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53489-141-01 | EA - Each | 53489-141 | d05c2cbe-a6a4-4b9f-979e-c6ed8e605aee | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Quinidine Gluconate | ACTIVE INGREDIENT | R6875N380F | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| Quinidine | ACTIVE MOIETY | ITX08688JL | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 3 | |
| Quinidine Gluconate | ACTIVE INGREDIENT | R6875N380F | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| Quinidine | ACTIVE MOIETY | ITX08688JL | QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Quinidine Gluconate | QUINIDINE GLUCONATE | Golden State Medical Supply | ad2ad985-cca2-25b5-e053-2995a90a402f | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 089338 ANDA089338 |
| Quinidine Gluconate | QUINIDINE GLUCONATE | Sun Pharmaceutical Industries, Inc. | 5023f053-fcc4-4c2c-aa59-9ec198ad185e | 2018-02-01 | Boxed warning, Warnings, Adverse reactions | 089338 ANDA089338 53489-141 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 852920 | quiNIDine gluconate 324 MG Extended Release Oral Tablet | PSN | 5023f053-fcc4-4c2c-aa59-9ec198ad185e | 5 |
| 852920 | quinidine gluconate 324 MG Extended Release Oral Tablet | SCD | 5023f053-fcc4-4c2c-aa59-9ec198ad185e | 5 |
| 852920 | quiNIDine gluconate 324 MG Extended Release Oral Tablet | PSN | 3af30c3b-944e-4293-baa5-38965b1d1137 | 3 |
| 852920 | quinidine gluconate 324 MG Extended Release Oral Tablet | SCD | 3af30c3b-944e-4293-baa5-38965b1d1137 | 3 |
| 852920 | quiNIDine gluconate 324 MG Extended Release Oral Tablet | PSN | ad2ad985-cca2-25b5-e053-2995a90a402f | 2 |
| 852920 | quinidine gluconate 324 MG Extended Release Oral Tablet | SCD | ad2ad985-cca2-25b5-e053-2995a90a402f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53489-141-01 | 53489014101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-03 | 53489014103 | 250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-05 | 53489014105 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-06 | 53489014106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-07 | 53489014107 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-10 | 53489014110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10) | 1987-02-10 | 0000-00-00 | No | No | Current |
| 53489-141-90 | 53489014190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90) | 1987-02-10 | 0000-00-00 | No | No | Current |