Prescription drug · ANDA
Chlordiazepoxide and Amitriptyline Hydrochloride NDC 0378-0211
Chlordiazepoxide 5 mg/1; Amitriptyline hydrochloride 14 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0211-01 | 00378021101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)Marketed from Dec 10, 1986 | |
| 0378-0211-05 | 00378021105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)Marketed from Dec 10, 1986 |
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)
- Chlordiazepoxide and Amitriptyline Hydrochloride
- Generic name (nonproprietary)
- chlordiazepoxide and amitriptyline hydrochloride
- Active ingredients
- Chlordiazepoxide — 5 mg/1Amitriptyline hydrochloride — 14 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071297
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0378-0211_20875d8f-5848-4892-a7fb-ab36b0288215SPL ID 20875d8f-5848-4892-a7fb-ab36b0288215SPL set ID 66a756f2-ac77-451c-a19a-08896d73b15cRxCUI 856769, 856792UNII 26LUD4JO9K, 6RZ6XEZ3CRUPC 0303780277014, 0303780211018
- Pharmacologic class
- Benzodiazepine; Tricyclic Antidepressant
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
N400378021101followed by a unit qualifier and the quantityPackage 00378-0211-01. 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 Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071297
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 |
|---|---|---|---|---|
| Chlordiazepoxide and Amitriptyline Hydrochloride | Chlordiazepoxide 10 mg/1; Amitriptyline hydrochloride 27.98 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0277 |