Prescription drug · ANDA
Promethazine Hydrochloride NDC 70752-138
Promethazine hydrochloride 6.25 mg/5mL · Solution · Oral · QUAGEN PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70752-138-06 | 70752013806 | 118 mL in 1 BOTTLE, PLASTIC (70752-138-06)Marketed from Jul 12, 2021 | |
| 70752-138-12 | 70752013812 | 473 mL in 1 BOTTLE, PLASTIC (70752-138-12)Marketed from Jul 12, 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)
- Promethazine Hydrochloride
- Generic name (nonproprietary)
- promethazine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- QUAGEN PHARMACEUTICALS LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213890
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 70752-138_63b61b41-3490-4c96-a50d-778498b51899SPL ID 63b61b41-3490-4c96-a50d-778498b51899SPL set ID 32022e66-6f76-430a-8ad2-1e9e2872fee1RxCUI 992432UNII R61ZEH7I1IUPC 0370752138123
- 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
N470752013806followed by a unit qualifier and the quantityPackage 70752-0138-06. 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 Promethazine is 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, or 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 control of post-operativ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213890
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 6.25 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2071 |