Prescription drug · ANDA
Quetiapine Fumarate NDC 29300-150
Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-150-01 | 2930001500129300015001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-01)Marketed from Jul 1, 2016 | |
| 29300-150-10 | 2930001501029300015010 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-10)Marketed from May 23, 2017 | |
| 29300-150-16 | 2930001501629300015016 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-16)Marketed from Jul 1, 2016 |
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 Fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
- Marketing start
- Listing expires
- Identifiers
- Product ID 29300-150_9054a1a7-c7ea-4630-be0b-2dcbe910ca94SPL ID 9054a1a7-c7ea-4630-be0b-2dcbe910ca94SPL set ID bdc9354b-172e-4bb3-895a-6c7cfef0ef14RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0329300150162
- 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
N429300015001followed by a unit qualifier and the quantityPackage 29300-0150-01. 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 tablets, USP are an atypical antipsychotic indicated for the treatment of Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine tablets, USP are indicated for the treatment of schizophrenia. The efficacy of Quetiapine tablets, USP in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of Quetiapine tablets, USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies ( 14.1 ) ]. 1.2 Bipolar Disorder Quetiapine tablets, USP are indicated fo…
Excerpt only. Read the full label for complete information.
About NDC 29300-150
- What is NDC 29300-150?
- 29300-150 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 200 mg/1 tablet, film coated, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine Fumarate.
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 Fumarate?
- 214 other product NDCs are listed under this name. See all Quetiapine Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine Fumarate 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 Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4701 | 70518-4701-00 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4705 | 70518-4705-00 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 25 mg/1 | TabletOral | Coupler LLC | 67046-1116 | 67046-1116-03 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 | 87441-0074-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 | 87441-0073-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-071 | 87441-0071-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-072 | 87441-0072-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Coupler LLC | 67046-0638 | 67046-0638-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0636 | 67046-0636-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Coupler LLC | 67046-0637 | 67046-0637-03 |
Other NDCs under ANDA 202674
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 Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8470 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8471 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8472 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8473 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8474 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8568 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-147 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-148 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-149 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-151 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-152 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3377 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3983 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1649 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3931 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2175 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3747 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1353 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0184 |