Prescription drug · ANDA
Chlorpromazine hydrochloride NDC 16714-050
Chlorpromazine hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-050-01 | 1671400500116714005001 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-050-01)Marketed from May 11, 2020 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213368
- Marketing start
- Marketing end
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 16714-050_a9a33076-fd77-4ae1-bff2-d4a4511a772aSPL ID a9a33076-fd77-4ae1-bff2-d4a4511a772aSPL set ID 2bd42d3a-bf89-4d74-a252-9b914106a570RxCUI 991039, 991044, 991188, 991194, 991336UNII 9WP59609J6
- 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
N416714005001followed by a unit qualifier and the quantityPackage 16714-0050-01. 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.
About NDC 16714-050
- What is NDC 16714-050?
- 16714-050 is the product NDC for Chlorpromazine hydrochloride, Chlorpromazine hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Northstar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorpromazine hydrochloride.
- What is the active ingredient?
- Chlorpromazine hydrochloride.
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlorpromazine hydrochloride?
- 106 other product NDCs are listed under this name. See all Chlorpromazine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlorpromazine 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) |
|---|---|---|---|---|---|
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 25 mg/1 | Tablet, Sugar coatedOral | American Health Packaging | 60687-938 | 60687-0938-0160687-0938-65 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 50 mg/1 | Tablet, Sugar coatedOral | American Health Packaging | 60687-949 | 60687-0949-01 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 100 mg/1 | Tablet, Sugar coatedOral | American Health Packaging | 60687-960 | 60687-0960-01 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 200 mg/1 | Tablet, Sugar coatedOral | American Health Packaging | 60687-971 | 60687-0971-01 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 100 mg/mL | ConcentrateOral | Saptalis Pharmaceuticals, LLC. | 71656-101 | 71656-0101-08 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 30 mg/mL | ConcentrateOral | Saptalis Pharmaceuticals, LLC. | 71656-102 | 71656-0102-04 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 25 mg/mL | InjectionIntramuscular | Novadoz Pharmaceuticals LLC | 72205-190 | 72205-0190-25 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 25 mg/mL | InjectionIntramuscular | Novadoz Pharmaceuticals LLC | 72205-191 | 72205-0191-25 |
| Chlorpromazine Hydrochloride | Chlorpromazine hydrochloride 25 mg/1 | Tablet, Sugar coatedOral | Coupler LLC | 67046-1633 | 67046-1633-03 |
| chlorpromazine hydrochloride | Chlorpromazine hydrochloride 30 mg/mL | ConcentrateOral | Advagen Pharma Ltd | 72888-457 | 72888-0457-01 |
Other NDCs under ANDA 213368
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 | Northstar Rx LLC | 16714-047 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1129 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1130 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1131 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1132 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 200 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1133 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1506 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1507 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1508 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1509 |
| Chlorpromazine hydrochloride | Chlorpromazine hydrochloride 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1510 |