Prescription drug · ANDA
Promethegan (promethazine hydrochloride) NDC 55289-928
Promethazine hydrochloride 25 mg/1 · Suppository · Rectal · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-928-02 | 55289092802 | 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)Marketed from Jul 13, 2011 | |
| 55289-928-04 | 55289092804 | 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04)Marketed from Jul 13, 2011 | |
| 55289-928-06 | 55289092806 | 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06)Marketed from Jul 13, 2011 | |
| 55289-928-79 | 55289092879 | 1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)Marketed from Jul 13, 2011 |
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)
- Promethegan
- Generic name (nonproprietary)
- promethazine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 25 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040428
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 55289-928_419b860e-68c0-f896-e063-6294a90aceb9SPL ID 419b860e-68c0-f896-e063-6294a90aceb9SPL set ID 6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97UNII R61ZEH7I1IUPC 0355289928041
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N455289092802followed by a unit qualifier and the quantityPackage 55289-0928-02. 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 HCl Suppositories, USP 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, 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040428
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 |
|---|---|---|---|---|
| Prometheganpromethazine hydrochloride | Promethazine hydrochloride 25 mg/1 | SuppositoryRectal | Cosette Pharmaceuticals, Inc. | 0713-0526 |
| Prometheganpromethazine hydrochloride | Promethazine hydrochloride 12.5 mg/1 | SuppositoryRectal | Cosette Pharmaceuticals, Inc. | 0713-0536 |