What is NDC 53489-500?

53489-500 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 53489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Thioridazine Hydrochloride?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Thioridazine Hydrochloride NDC 53489-500

NDC codes

FDA NDC Directory

Product NDC (as listed)53489-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53489-0500Add 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
53489-500-01	53489050001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01)Marketed from Oct 7, 1988
53489-500-02	53489050002	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02)Marketed from Oct 7, 1988
53489-500-03	53489050003	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03)Marketed from Oct 7, 1988
53489-500-05	53489050005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05)Marketed from Oct 7, 1988
53489-500-06	53489050006	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06)Marketed from Oct 7, 1988
53489-500-10	53489050010	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10)Marketed from Oct 7, 1988
53489-500-60	53489050060	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60)Marketed from Oct 7, 1988

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): Thioridazine Hydrochloride
Generic name (nonproprietary): thioridazine hydrochloride
Active ingredients: Thioridazine hydrochloride — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 53489
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089953
Marketing start: Oct 7, 1988
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 53489-500_2c96c6f9-3008-48ba-86ea-e9b83502da67SPL ID 2c96c6f9-3008-48ba-86ea-e9b83502da67SPL set ID 9c4bedb4-2d59-4fcd-aad7-fce988cd96d8RxCUI 198270, 198274, 198275, 313354UNII 4WCI67NK8M
Pharmacologic class: Phenothiazine

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

N453489050001 followed by a unit qualifier and the quantity

Package 53489-0500-01. 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 Oct 20, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Thioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine hydrochloride tabl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53489-500

What is NDC 53489-500?: 53489-500 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Thioridazine Hydrochloride.
What is the active ingredient?: Thioridazine hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 53489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thioridazine Hydrochloride?: 19 other product NDCs are listed under this name. See all Thioridazine Hydrochloride 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 Thioridazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-095	48433-0095-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-096	48433-0096-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-097	48433-0097-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-098	48433-0098-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 100 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-580	51079-0580-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 50 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-567	51079-0567-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-565	51079-0565-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-566	51079-0566-20
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	53489-148	53489-0148-0153489-0148-10
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	53489-149	53489-0149-0153489-0149-10

All 20 Thioridazine Hydrochloride NDCs

Other NDCs under ANDA 089953

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

FDA NDC Directory listings under ANDA 089953
Product	Strength	Form · route	Labeler	Product NDC
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	53489-148
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	53489-149
Thioridazine Hydrochloride	Thioridazine hydrochloride 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	53489-150