Promethazine Hydrochloride NDC 31722-040

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-040Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0040Add 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
31722-040-31	31722004031	2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACKMarketed from Nov 2, 2022

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 — 12.5 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216446
Marketing start: Nov 2, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 31722-040_ecb3a4da-a4fc-7803-e053-2a95a90a0f3fSPL ID ecb3a4da-a4fc-7803-e053-2a95a90a0f3fSPL set ID ba7d9e82-9b13-4607-b2f9-25e575b8c73bRxCUI 992441, 992454UNII R61ZEH7I1IUPC 0331722040310, 0331722041317
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

N431722004031 followed by a unit qualifier and the quantity

Package 31722-0040-31. 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 5, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine hydrochloride suppositories 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216446

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

FDA NDC Directory listings under ANDA 216446
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	Camber Pharmaceuticals, Inc.	31722-041