Quetiapine
- Product NDC
- 16729-149
- 11-digit product format
- 167290149
- Labeler code
- 16729
- Product ID
- 16729-149_438f950d-730b-8926-e063-6294a90a8f66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA202152
- Marketing category
- ANDA
- Marketing start
- 2012-03-28
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 300 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 |
|---|
| 16729-149-00 | Quetiapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
| 16729-149-01 | Quetiapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
| 16729-149-10 | Quetiapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 16729-149-12 | Quetiapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 17 |
| 16729-149-17 | Quetiapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 17 |
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 [ACCORD HEALTHCARE INC.] | 5 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-149 | QUETIAPINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 16 | Current NDC, Legacy NDC, 5 package rows | 20240719_2d77412a-e084-4406-ac33-d882aece9354.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 |
|---|
| 16729-149-00 | 16729014900 | 100 in 1 BOTTLE | | | | | Historical |
| 16729-149-01 | 16729014901 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-149-01) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 16729-149-10 | 16729014910 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-149-10) | 2012-03-28 | 0000-00-00 | No | No | Current |
| 16729-149-12 | 16729014912 | 60 TABLET, FILM COATED in 1 BOTTLE (16729-149-12) | 2012-03-28 | 0000-00-00 | No | No | Current |
| 16729-149-17 | 16729014917 | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-149-17) | 2012-03-28 | 0000-00-00 | No | No | Current |
| 16729-149-18 | 16729014918 | 2000 TABLET, FILM COATED in 1 CONTAINER (16729-149-18) | 16-DEC-15 | | | | Current |