SEROQUEL
- Product NDC
- 21695-119
- 11-digit product format
- 216950119
- Labeler code
- 21695
- Product ID
- 21695-119_3dc79540-2f24-4920-99cd-ef6482f68eb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA020639
- Marketing category
- NDA
- Marketing start
- 2010-06-01
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-119-15 | SEROQUEL | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 21695-119-30 | SEROQUEL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| QUETIAPINE FUMARATE | ACTIVE INGREDIENT | 2S3PL1B6UJ | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-119 | SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110622_3dc79540-2f24-4920-99cd-ef6482f68eb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-119-15 | 21695011915 | 15 in 1 BOTTLE | Historical |
| 21695-119-30 | 21695011930 | 30 in 1 BOTTLE | Historical |