Prescription drug · ANDA
Quetiapine Extended-Release (Quetiapine) NDC 69948-002
Quetiapine fumarate 150 mg/1 · Tablet, Film coated, Extended release · Oral · AlignScience Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69948-002-03 | 6994800020369948000203 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-002-03)Marketed from Dec 30, 2025 | |
| 69948-002-11 | 6994800021169948000211 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-002-11)Marketed from Dec 30, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Quetiapine Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 150 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AlignScience Pharma Inc.NDC labeler code 69948
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209497
- Marketing start
- Listing expires
- Identifiers
- Product ID 69948-002_47232802-9e04-c181-e063-6394a90a9d90SPL ID 47232802-9e04-c181-e063-6394a90a9d90SPL set ID db3ba268-21a2-4988-b5c1-353741bcaee5RxCUI 721791, 895670UNII 2S3PL1B6UJUPC 0369948002034, 0369948003031, 0369948003116, 0369948002119
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469948000203followed by a unit qualifier and the quantityPackage 69948-0002-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Quetiapine extended-release tablets is an atypical antipsychotic indicated for the treatment of: •Schizophrenia (1.1) •Bipolar I disorder, manic or mixed episodes (1.2) •Bipolar disorder, depressive episodes (1.2) •Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets is indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated…
Excerpt only. Read the full label for complete information.
About NDC 69948-002
- What is NDC 69948-002?
- 69948-002 is the product NDC for Quetiapine Extended-Release (quetiapine), Quetiapine fumarate 150 mg/1 tablet, film coated, extended release, listed with the FDA by AlignScience Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine Extended-Release (Quetiapine).
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- AlignScience Pharma Inc., NDC labeler code 69948. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quetiapine Extended-Release?
- 20 other product NDCs are listed under this name. See all Quetiapine Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine Extended-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4769 | 70518-4769-00 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4051 | 70518-4051-00 |
| Quetiapine Extended-Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | AlignScience Pharma Inc. | 69948-003 | 69948-0003-0369948-0003-11 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-799 | 51407-0799-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-380 | 50228-0380-1050228-0380-3050228-0380-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-381 | 50228-0381-1050228-0381-3050228-0381-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-382 | 50228-0382-1050228-0382-3050228-0382-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-383 | 50228-0383-0550228-0383-3050228-0383-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-384 | 50228-0384-0550228-0384-3050228-0384-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-800 | 51407-0800-60 |
Other NDCs under ANDA 209497
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Quetiapine Extended-Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | AlignScience Pharma Inc. | 69948-003 |