Promethegan (promethazine hydrochloride) NDC 0713-0536

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0536Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0536Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0713-0536-10	00713053610	1000 SUPPOSITORY in 1 BOX (0713-0536-10)Marketed from Feb 28, 2004
0713-0536-12	00713053612	12 SUPPOSITORY in 1 BOX (0713-0536-12)Marketed from Feb 28, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 12.5 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Cosette Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040428
Marketing start: Feb 28, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0713-0536_0b622b7b-a45f-eab0-e063-6394a90a0c0aSPL ID 0b622b7b-a45f-eab0-e063-6394a90a0c0aSPL set ID 5f079815-f48b-8b21-2130-7f791d967c9aRxCUI 992441, 992445, 992454, 992459UNII 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 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

N400713053610 followed by a unit qualifier and the quantity

Package 00713-0536-10. 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 Nov 30, 2023. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040428

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040428
Product	Strength	Form · route	Labeler	Product NDC
Prometheganpromethazine hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	PD-Rx Pharmaceuticals, Inc.	55289-928
Prometheganpromethazine hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	Cosette Pharmaceuticals, Inc.	0713-0526