Prescription drug · ANDA
promethazine hydrochloride NDC 27808-051
Promethazine hydrochloride 6.25 mg/5mL · Syrup · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-051-02 | 27808005102 | 473 mL in 1 BOTTLE (27808-051-02)Marketed from Sep 30, 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
- Syrup
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091675
- Marketing start
- Marketing end
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 27808-051_f00d9daa-3d9f-4645-b4a2-ecef6f85bab2SPL ID f00d9daa-3d9f-4645-b4a2-ecef6f85bab2SPL set ID d32ea9db-11d4-400d-b7ef-dd0ec01b796dRxCUI 992432UNII R61ZEH7I1I
- 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
N427808005102followed by a unit qualifier and the quantityPackage 27808-0051-02. 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 Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) 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 adjun…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091675
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 | SyrupOral | A-S Medication Solutions | 50090-6431 |
| promethazine hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SyrupOral | ATLANTIC BIOLOGICALS CORP | 17856-0059 |