What is NDC 0054-0221?

0054-0221 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 100 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Quetiapine Fumarate NDC 0054-0221 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0221Add 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 NDC	11-digit (billing)	Package	Copy
0054-0221-20	0005402212000054022120	10 BLISTER PACK in 1 CARTON (0054-0221-20) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 27, 2012
0054-0221-25	0005402212500054022125	100 TABLET in 1 BOTTLE (0054-0221-25)Marketed from Mar 27, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090749
Marketing start: Mar 27, 2012
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0221_73eed8f1-3912-40e6-8084-d8498616ee5dSPL ID 73eed8f1-3912-40e6-8084-d8498616ee5dSPL set ID 271e9fb7-3c70-43fc-8279-5adf189f3c22RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0300540223212, 0300540230258, 0300540222253, 0300540229252, 0300540220259, 0300540221256
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

N400054022120 followed by a unit qualifier and the quantity

Package 00054-0221-20. 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 Feb 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Quetiapine 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 is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 is indicated for the acute treatment of manic episodes associated with bipo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0221

What is NDC 0054-0221?: 0054-0221 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 100 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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
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

All 215 Quetiapine Fumarate NDCs

Other NDCs under ANDA 090749

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

FDA NDC Directory listings under ANDA 090749
Product	Strength	Form · route	Labeler	Product NDC
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0222
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0223
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0229
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0230
Quetiapine Fumarate	Quetiapine fumarate 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-067
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-068
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-069
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-070
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-071
Quetiapine Fumarate	Quetiapine fumarate 300 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-127
Quetiapine Fumarate	Quetiapine fumarate 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-128
Quetiapine Fumarate	Quetiapine fumarate 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-136
Quetiapine Fumarate	Quetiapine fumarate 400 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-141