Quetiapine fumarate
- Product NDC
- 63187-219
- 11-digit product format
- 631870219
- Labeler code
- 63187
- Product ID
- 63187-219_2fb97f0d-ad18-445a-b9a5-f128ae90cfc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202152
- Marketing category
- ANDA
- Marketing start
- 2012-03-26
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-219-30 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 63187-219-60 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
| 63187-219-90 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 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 [PROFICIENT RX LP] | 2 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-219 | QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP] | 7 | Current NDC, Legacy NDC, 3 package rows | 20220517_8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60.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 |
|---|
| 63187-219-30 | 63187021930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-219-30) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-219-60 | 63187021960 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-219-60) | 2014-09-02 | 0000-00-00 | No | No | Current |
| 63187-219-90 | 63187021990 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-219-90) | 2014-09-01 | 0000-00-00 | No | No | Current |