Prescription drug · ANDA
Chlorpromazine Hydrochloride NDC 68462-863
Chlorpromazine hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-863-01 | 68462086301 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-863-01)Marketed from Mar 23, 2021 | |
| 68462-863-10 | 68462086310 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-863-10)Marketed from Mar 23, 2021 |
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)
- Chlorpromazine Hydrochloride
- Generic name (nonproprietary)
- chlorpromazine hydrochloride
- Active ingredients
- Chlorpromazine hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212144
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 68462-863_440a4208-83cc-4ffa-952c-d9c0745c342aSPL ID 440a4208-83cc-4ffa-952c-d9c0745c342aSPL set ID a6065ac5-a111-449b-b51b-8bc2907d1ddbRxCUI 991039, 991044, 991188, 991194, 991336UNII 9WP59609J6UPC 0368462862018, 0368462864012, 0368462863015, 0368462861011
- 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
N468462086301followed by a unit qualifier and the quantityPackage 68462-0863-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanyi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212144
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-861 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 200 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-865 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-862 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-864 |