Quetiapine Fumarate
- Product NDC
- 64725-8166
- 11-digit product format
- 647258166
- Labeler code
- 64725
- Product ID
- 64725-8166_bf422cc2-9c69-4cf2-9a5b-22adee95ccf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA077745
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 |
|---|
| 64725-8166-1 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
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 [TYA PHARMACEUTICALS] | 2 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64725-8166 | QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140927_daec35ae-a9e7-494a-90a6-c8aff1c65c71.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64725-8166-1 | 64725816601 | 100 in 1 BOTTLE | Historical |