Quetiapine Fumarate
- Product NDC
- 65862-493
- 11-digit product format
- 658620493
- Labeler code
- 65862
- Product ID
- 65862-493_f759dcc0-2e6c-4743-8772-3f05602db2a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- 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
- 2026-12-31
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, 389201, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-493-01 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 19 |
| 65862-493-10 | Quetiapine Fumarate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 19 |
| 65862-493-10 | Quetiapine Fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 19 |
| 65862-493-99 | Quetiapine Fumarate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 19 |
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 [AUROBINDO PHARMA LIMITED] | 6 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-493 | QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250308_8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6.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 |
|---|
| 65862-493-01 | 65862049301 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-493-01) | | 2012-03-27 | 0000-00-00 | No | No | Current |
| 65862-493-10 | 65862049310 | 10 BLISTER PACK in 1 CARTON (65862-493-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-03-27 | 0000-00-00 | No | No | Current |
| 65862-493-99 | 65862049399 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-493-99) | | 2012-03-27 | 0000-00-00 | No | No | Current |