NDC codes

FDA NDC Directory
Product NDC (as listed)51079-567Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0567Add 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
51079-567-2051079056720100 BLISTER PACK in 1 CARTON (51079-567-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-567-01)Marketed from May 6, 1998

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 — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Mylan Institutional Inc.NDC labeler code 51079
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088004
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 51079-567_4358c933-3022-792d-e063-6294a90aacb6SPL ID 4358c933-3022-792d-e063-6294a90aacb6SPL set ID 52fea941-0b47-41c1-b00d-f88150e8ab93RxCUI 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

N451079056720 followed by a unit qualifier and the quantity

Package 51079-0567-20. 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 . 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 51079-567

What is NDC 51079-567?
51079-567 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Mylan Institutional 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 Institutional Inc., NDC labeler code 51079. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralSafecor Health LLC48433-09548433-0095-20
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralSafecor Health LLC48433-09648433-0096-20
Thioridazine HydrochlorideThioridazine hydrochloride 50 mg/1Tablet, Film coatedOralSafecor Health LLC48433-09748433-0097-20
Thioridazine HydrochlorideThioridazine hydrochloride 100 mg/1Tablet, Film coatedOralSafecor Health LLC48433-09848433-0098-20
Thioridazine HydrochlorideThioridazine hydrochloride 100 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-58051079-0580-20
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-56551079-0565-20
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-56651079-0566-20
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.53489-14853489-0148-0153489-0148-10
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.53489-14953489-0149-0153489-0149-10
Thioridazine HydrochlorideThioridazine hydrochloride 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.53489-15053489-0150-0153489-0150-10

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
ProductStrengthForm · routeLabelerProduct NDC
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralSafecor Health LLC48433-095
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-565
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-566
Thioridazine HydrochlorideThioridazine hydrochloride 100 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-580
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralSafecor Health LLC48433-096
Thioridazine HydrochlorideThioridazine hydrochloride 50 mg/1Tablet, Film coatedOralSafecor Health LLC48433-097
Thioridazine HydrochlorideThioridazine hydrochloride 100 mg/1Tablet, Film coatedOralSafecor Health LLC48433-098
Thioridazine HydrochlorideThioridazine hydrochloride 10 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0612
Thioridazine HydrochlorideThioridazine hydrochloride 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0614
Thioridazine HydrochlorideThioridazine hydrochloride 50 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0616
Thioridazine HydrochlorideThioridazine hydrochloride 100 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-0618

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