Prescription drug · ANDA

Quetiapine fumarate NDC 70518-2752

Quetiapine fumarate 400 mg/1 · Tablet · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2752Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2752Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70518-2752-07051827520030 TABLET in 1 BLISTER PACK (70518-2752-0)Marketed from May 26, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 400 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
Marketing start
Listing expires
Identifiers
Product ID 70518-2752_57afede2-23b6-c9e6-e063-6394a90abd35SPL ID 57afede2-23b6-c9e6-e063-6394a90abd35SPL set ID d38f0f4e-dc0f-4c92-a212-c4da3db74801RxCUI 616483UNII 2S3PL1B6UJ
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

N470518275200 followed by a unit qualifier and the quantity

Package 70518-2752-00. 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 tablet is 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 are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets 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 are indicated for the acute treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-2752

What is NDC 70518-2752?
70518-2752 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 400 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
REMEDYREPACK INC., NDC labeler code 70518. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Quetiapine fumarate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Quetiapine FumarateQuetiapine fumarate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470170518-4701-00
Quetiapine FumarateQuetiapine fumarate 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470570518-4705-00
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralCoupler LLC67046-111667046-1116-03
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralUnit Dose Solutions, Inc.87441-07387441-0073-01
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralUnit Dose Solutions, Inc.87441-07487441-0074-01
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-07187441-0071-01
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralUnit Dose Solutions, Inc.87441-07287441-0072-01
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralCoupler LLC67046-063867046-0638-03
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralCoupler LLC67046-063667046-0636-03
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralCoupler LLC67046-063767046-0637-03

All 215 Quetiapine fumarate NDCs

Other NDCs under ANDA 201109

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 201109
ProductStrengthForm · routeLabelerProduct NDC
Quetiapine fumaratequetiapineQuetiapine fumarate 400 mg/1TabletOralAmerican Health Packaging60687-382
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralAmerican Health Packaging60687-327
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0413
Quetiapine fumaratequetiapineQuetiapine fumarate 50 mg/1TabletOralAmerican Health Packaging60687-338
Quetiapine fumaratequetiapineQuetiapine fumarate 100 mg/1TabletOralAmerican Health Packaging60687-349
Quetiapine fumaratequetiapineQuetiapine fumarate 200 mg/1TabletOralAmerican Health Packaging60687-360
Quetiapine fumaratequetiapineQuetiapine fumarate 300 mg/1TabletOralAmerican Health Packaging60687-371
Quetiapine fumaratequetiapineQuetiapine fumarate 25 mg/1TabletOralCoupler LLC67046-1116
Quetiapine fumarateQuetiapine fumarate 300 mg/1TabletOralBryant Ranch Prepack71335-2278
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-448
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-445
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-446
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-447
Quetiapine fumarateQuetiapine fumarate 50 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-096
Quetiapine fumarateQuetiapine fumarate 300 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-449
Quetiapine fumarateQuetiapine fumarate 400 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-450
Quetiapine fumarateQuetiapine fumarate 25 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-095
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8746
Quetiapine fumarateQuetiapine fumarate 100 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-097
Quetiapine fumarateQuetiapine fumarate 200 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-098

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Quetiapine fumarate NDC 70518-2752 | National Drug Code | Med-Code