Prescription drug · ANDA

Promethazine Hydrochloride NDC 50090-4875

Promethazine hydrochloride 25 mg/1 · Tablet · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4875Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4875Add 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
50090-4875-05009048750012 TABLET in 1 BOTTLE (50090-4875-0)Marketed from Feb 3, 2020

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
A-S Medication SolutionsNDC labeler code 50090
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 50090-4875_78bcbe8f-26ba-42f2-927d-3ad100e16f33SPL ID 78bcbe8f-26ba-42f2-927d-3ad100e16f33SPL set ID 69eea039-0098-4e2f-a832-152583b16f05RxCUI 992447UNII 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

N450090487500 followed by a unit qualifier and the quantity

Package 50090-4875-00. 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 50090-4875

What is NDC 50090-4875?
50090-4875 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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?
114 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 50 mg/1TabletOralCoupler LLC67046-144767046-1447-03
Promethazine HydrochloridePromethazine hydrochloride 6.25 mg/5mLSolutionOralKesin Pharma Corporation81033-01681033-0016-50
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-337355154-3373-00

All 115 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
Phenerganpromethazine hclPromethazine hydrochloride 12.5 mg/1TabletOralDirect_Rx72189-402
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8154
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4811
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4812
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-4813
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralAmerican Health Packaging60687-660
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralBryant Ranch Prepack63629-1591
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralZydus Lifesciences Limited65841-040
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralZydus Lifesciences Limited65841-041
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralZydus Lifesciences Limited65841-042
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralCoupler LLC67046-1043
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralCoupler LLC67046-1447
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralRedpharm Drug67296-0198
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralBluePoint Laboratories68001-161
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralBluePoint Laboratories68001-162
Promethazine HydrochloridePromethazine hydrochloride 50 mg/1TabletOralBluePoint Laboratories68001-163
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4809
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4865
Promethazine HydrochloridePromethazine hydrochloride 25 mg/1TabletOralAmerican Health Packaging68084-155
Promethazine HydrochloridePromethazine hydrochloride 12.5 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-040

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