Promethazine Hydrochloride NDC 68071-4544

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4544Add 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
68071-4544-2	68071454402	12 TABLET in 1 BOTTLE (68071-4544-2)Marketed from Aug 28, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 083426
Marketing start: Sep 19, 1973
Marketing end: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 68071-4544_2dd17384-f3a5-70d3-e063-6294a90aeb7fSPL ID 2dd17384-f3a5-70d3-e063-6294a90aeb7fSPL set ID 74834e1b-0d90-0542-e053-2991aa0aa1efRxCUI 992447UNII R61ZEH7I1IUPC 0368071454420
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

N468071454402 followed by a unit qualifier and the quantity

Package 68071-4544-02. 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 Feb 10, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine hydrochloride tablets 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 c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 083426

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

FDA NDC Directory listings under ANDA 083426
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Actavis Pharma, Inc.	0591-5307
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-140
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Proficient Rx LP	63187-829