What is NDC 0378-0616?

0378-0616 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-0616

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0616Add 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
0378-0616-01	00378061601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0616-01)Marketed from Mar 15, 1983

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): Thioridazine Hydrochloride
Generic name (nonproprietary): thioridazine hydrochloride
Active ingredients: Thioridazine hydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088004
Marketing start: Mar 15, 1983
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0378-0616_6437f615-1e2b-4d0a-ba83-a0c14391693dSPL ID 6437f615-1e2b-4d0a-ba83-a0c14391693dSPL set ID 56b3f4c2-52af-4947-b225-6808ae9f26f5RxCUI 198270, 198274, 198275, 313354UNII 4WCI67NK8MUPC 0303780618015, 0303780616011, 0303780612013, 0303780614017
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

N400378061601 followed by a unit qualifier and the quantity

Package 00378-0616-01. 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 Jan 15, 2025. 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 0378-0616

What is NDC 0378-0616?: 0378-0616 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 088004

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

FDA NDC Directory listings under ANDA 088004
Product	Strength	Form · route	Labeler	Product NDC
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-566
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-095
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-096
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-565
Thioridazine Hydrochloride	Thioridazine hydrochloride 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-097
Thioridazine Hydrochloride	Thioridazine hydrochloride 50 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-567
Thioridazine Hydrochloride	Thioridazine hydrochloride 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-098
Thioridazine Hydrochloride	Thioridazine hydrochloride 100 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-580
Thioridazine Hydrochloride	Thioridazine hydrochloride 10 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0612
Thioridazine Hydrochloride	Thioridazine hydrochloride 25 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0614
Thioridazine Hydrochloride	Thioridazine hydrochloride 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0618