Quetiapine fumarate
- Product NDC
- 47335-905
- 11-digit product format
- 473350905
- Labeler code
- 47335
- Product ID
- 47335-905_c8178883-9da2-4b4f-88ee-182d628a2e41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201190
- Marketing category
- ANDA
- Marketing start
- 2012-03-28
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-905-18 | Quetiapine fumarate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 23 |
| 47335-905-61 | Quetiapine fumarate | 10 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 10 | | 23 |
| 47335-905-61 | Quetiapine fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 23 |
| 47335-905-83 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 47335-905-88 | Quetiapine fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 23 |
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 [SUN PHARMA GLOBAL FZE] | 12 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-905 | QUETIAPINE FUMARATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 23 | Current NDC, Legacy NDC, 5 package rows | 20250308_ffe52b98-9872-48c1-90fd-8fcd37c3432f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-905-18 | 47335090518 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-905-18) | | 2012-03-28 | 0000-00-00 | No | No | Current |
| 47335-905-61 | 47335090561 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-905-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-03-28 | 0000-00-00 | No | No | Current |
| 47335-905-83 | 47335090583 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-905-83) | | 2012-03-28 | 0000-00-00 | No | No | Current |
| 47335-905-88 | 47335090588 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-905-88) | | 2012-03-28 | 0000-00-00 | No | No | Current |