Prescription drug · ANDA
Promethazine Hydrochloride NDC 62135-774
Promethazine hydrochloride 6.25 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-774-23 | 62135077423 | 2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10)Marketed from Feb 10, 2025 | |
| 62135-774-24 | 62135077424 | 2 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05)Marketed from Feb 10, 2025 | |
| 62135-774-41 | 62135077441 | 120 mL in 1 BOTTLE (62135-774-41)Marketed from Nov 27, 2023 | |
| 62135-774-47 | 62135077447 | 473 mL in 1 BOTTLE (62135-774-47)Marketed from Nov 27, 2023 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040026
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 62135-774_499ebc74-646b-4e6d-e063-6394a90ab998SPL ID 499ebc74-646b-4e6d-e063-6394a90ab998SPL set ID 2ca17cd4-460e-4d54-8c53-a58a2b80e5cbRxCUI 992432UNII R61ZEH7I1IUPC 0362135774417, 0362135774479
- 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
N462135077423followed by a unit qualifier and the quantityPackage 62135-0774-23. 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 is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated 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 postoperative pain. Sed…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040026
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 | Chartwell Governmental & Specialty RX, LLC. | 68999-774 |