Prescription drug · ANDA
Thioridazine Hydrochloride NDC 62135-936
Thioridazine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-936-90 | 62135093690 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-936-90)Marketed from Feb 14, 2025 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088133
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 62135-936_2e81bd7d-c434-2d02-e063-6294a90a196dSPL ID 2e81bd7d-c434-2d02-e063-6294a90a196dSPL set ID e0bbe982-6434-468b-bd29-64ac57386fbeRxCUI 198270, 198274, 198275, 313354UNII 4WCI67NK8MUPC 0362135934903, 0362135936907, 0362135939908, 0362135938901
- 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
N462135093690followed by a unit qualifier and the quantityPackage 62135-0936-90. 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 is 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 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, it is strongly recommended that a patient be given at least tw…
Excerpt only. Read the full label for complete information.
About NDC 62135-936
- What is NDC 62135-936?
- 62135-936 is the product NDC for Thioridazine Hydrochloride, Thioridazine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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.
Related NDCs: other Thioridazine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |