Prescription drug · ANDA

Promethazine Hydrochloride NDC 67046-1447

Promethazine hydrochloride 50 mg/1 · Tablet · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1447Add 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
67046-1447-36704614470330 TABLET in 1 BLISTER PACK (67046-1447-3)Marketed from Feb 7, 2025

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 — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040596
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 67046-1447_2d996626-a75c-950a-e063-6394a90a9c24SPL ID 2d996626-a75c-950a-e063-6394a90a9c24SPL set ID 2d996287-9eed-265a-e063-6294a90a6969RxCUI 992475UNII 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

N467046144703 followed by a unit qualifier and the quantity

Package 67046-1447-03. 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, is useful orally 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 co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1447

What is NDC 67046-1447?
67046-1447 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 50 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Promethazine Hydrochloride.
What is the active ingredient?
Promethazine hydrochloride.
Who is the labeler?
Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Promethazine Hydrochloride?
116 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Promethazine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralNorthwind Health Company, LLC82868-11582868-0115-20
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralCoupler LLC67046-104367046-1043-03
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralUnit Dose Solutions, Inc.87441-07087441-0070-01
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-185400121-1854-16
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-441970518-4419-00
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSyrupOralXttrium Laboratories, Inc.0116-402300116-4023-16
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSyrupOralAtlantic Biologicals Corp.17856-402317856-4023-01
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSolutionOralKesin Pharma Corporation81033-01681033-0016-50
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-337355154-3373-00
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSolutionOralBryant Ranch Prepack72162-237772162-2377-02

All 117 Promethazine Hydrochloride NDCs

Other NDCs under ANDA 040596

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

FDA NDC Directory listings under ANDA 040596
ProductStrengthForm · routeLabelerProduct NDC
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralAmerican Health Packaging60687-660
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralASCLEMED USA INC.87063-015
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralASCLEMED USA INC.87063-016
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralSportpharm LLC85766-110
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralSportpharm LLC85766-108
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralSportpharm LLC85766-109
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralNorthwind Health Company, LLC82868-115
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralDIRECT RX72189-176
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-1306
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4811
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralBluePoint Laboratories68001-161
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4812
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralBluePoint Laboratories68001-162
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4813
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralBluePoint Laboratories68001-163
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-042
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralREMEDYREPACK INC.70518-2488
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-1139
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralBryant Ranch Prepack63629-1591
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4875

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