Quetiapine Fumarate
- Product NDC
- 46708-139
- 11-digit product format
- 467080139
- Labeler code
- 46708
- Product ID
- 46708-139_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA203390
- Marketing category
- ANDA
- Marketing start
- 2017-02-21
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-139-10 | 2023-02-01 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-30 | 2023-02-01 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-31 | 2023-02-01 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-71 | 2023-02-01 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-31 | 2023-01-30 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
| 46708-139-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-9936-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-139-10 | Quetiapine Fumarate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 7 |
| 46708-139-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 46708-139-31 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 46708-139-71 | Quetiapine Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| QUETIAPINE FUMARATE | ACTIVE INGREDIENT | 2S3PL1B6UJ | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-139 | QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 4 package rows | 20230202_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-139-10 | 46708013910 | 100 TABLET, FILM COATED in 1 CARTON (46708-139-10) | 2017-02-21 | 0000-00-00 | No | No | Current |
| 46708-139-30 | 46708013930 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-139-30) | 2017-02-21 | 0000-00-00 | No | No | Current |
| 46708-139-31 | 46708013931 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-139-31) | 2017-02-21 | 0000-00-00 | No | No | Current |
| 46708-139-71 | 46708013971 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-139-71) | 2017-02-21 | 0000-00-00 | No | No | Current |