Quetiapine
- Product NDC
- 16714-454
- 11-digit product format
- 167140454
- Labeler code
- 16714
- Product ID
- 16714-454_eed3c37a-4c97-52aa-e053-2995a90a2588
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar RxLLC
- Application
- ANDA202152
- Marketing category
- ANDA
- Marketing start
- 2015-12-01
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [NORTHSTAR RXLLC] | 1 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-454 | QUETIAPINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 10 | Legacy NDC | 20240718_f9d265a9-7491-48e1-a39e-0aaa67294cff.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 |
|---|
| 16714-454-01 | 16714045401 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-454-01) | 2015-12-01 | 0000-00-00 | No | No | Current |
| 16714-454-02 | 16714045402 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-454-02) | 2015-12-01 | 0000-00-00 | No | No | Current |