Prescription drug · ANDA
Promethazine Hydrochloride NDC 53746-522
Promethazine hydrochloride 50 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-522-01 | 53746052201 | 100 TABLET in 1 BOTTLE (53746-522-01)Marketed from Jun 22, 2022 |
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)
- Promethazine Hydrochloride
- Generic name (nonproprietary)
- promethazine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091179
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 53746-522_91a3c41d-efc8-4caa-8cec-1976ac46c000SPL ID 91a3c41d-efc8-4caa-8cec-1976ac46c000SPL set ID 0b5734b8-6a52-44ff-ac29-9a91a4335394RxCUI 992438, 992447, 992475UNII R61ZEH7I1IUPC 0353746522016
- 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
N453746052201followed by a unit qualifier and the quantityPackage 53746-0522-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for con…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091179
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 |
|---|---|---|---|---|
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-745 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-521 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-522 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3373 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7304 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-085 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-745 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-405 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-447 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-758 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-521 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6216 |