NDC codes

FDA NDC Directory
Product NDC (as listed)17856-0059Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-0059Add 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 NDC11-digit (billing)PackageCopy
17856-0059-11785600590172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Nov 13, 2023

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 — 6.25 mg/5mL
Dosage form
Syrup
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091675
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 17856-0059_45b43457-b9cd-09a2-e063-6294a90a698dSPL ID 45b43457-b9cd-09a2-e063-6294a90a698dSPL set ID 69934bbb-922c-4752-b253-f2f07340de8dRxCUI 992432UNII 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 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

N417856005901 followed by a unit qualifier and the quantity

Package 17856-0059-01. 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 Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is 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 adjun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091675

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

FDA NDC Directory listings under ANDA 091675
ProductStrengthForm · routeLabelerProduct NDC
promethazine hydrochloridePromethazine hydrochloride 6.25 mg/5mLSyrupOralA-S Medication Solutions50090-6431
promethazine hydrochloridePromethazine hydrochloride 6.25 mg/5mLSyrupOralCranbury Pharmaceuticals, LLC27808-051

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