NDC codes

FDA NDC Directory
Product NDC (as listed)0054-4184Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-4184Add 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
0054-4184-250005441842500054418425100 TABLET in 1 BOTTLE, PLASTIC (0054-4184-25)Marketed from Jul 19, 1978

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Dexamethasone
Generic name (nonproprietary)
dexamethasone
Active ingredients
Dexamethasone — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Hikma Pharmaceuticals USA, Inc.NDC labeler code 0054
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 084612
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 0054-4184_286734bc-8329-4f44-a20b-610cf7b67591SPL ID 286734bc-8329-4f44-a20b-610cf7b67591SPL set ID b15200fb-1826-472b-a907-e677a272513bRxCUI 197577, 197579, 197580, 197581, 197582, 197583, 309684, 309686, 343033UNII 7S5I7G3JQL
Pharmacologic class
Corticosteroid

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

N400054418425 followed by a unit qualifier and the quantity

Package 00054-4184-25. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocortico…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-4184

What is NDC 0054-4184?
0054-4184 is the product NDC for Dexamethasone, Dexamethasone 4 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexamethasone.
What is the active ingredient?
Dexamethasone.
Who is the labeler?
Hikma Pharmaceuticals USA, Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexamethasone?
134 other product NDCs are listed under this name. See all Dexamethasone 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 Dexamethasone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DexamethasoneDexamethasone 4 mg/1TabletOralPreferred Pharmaceuticals Inc68788-411368788-4113-0168788-4113-0368788-4113-05+1 more
DexamethasoneDexamethasone .5 mg/1TabletOralREMEDYREPACK INC.70518-466970518-4669-00
DexamethasoneDexamethasone .25 mg/1TabletOralPangea Pharmaceuticals, LLC81279-11781279-0117-60
DexamethasoneDexamethasone .5 mg/5mLElixirOralANI Pharmaceuticals, Inc.70954-87270954-0872-10
DexamethasoneDexamethasone 4 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-53472789-0534-0172789-0534-2872789-0534-95
DexamethasoneDexamethasone .5 mg/5mLElixirOralBryant Ranch Prepack72162-260072162-2600-02
DexamethasoneDexamethasone .5 mg/5mLElixirOralKanchan Healthcare Inc85742-00485742-0004-03
DexamethasoneDexamethasone 1.5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-396268071-3962-03
DexamethasoneDexamethasone .5 mg/1TabletOralAdvagen Pharma Ltd.72888-23572888-0235-01
DexamethasoneDexamethasone .75 mg/1TabletOralAdvagen Pharma Ltd.72888-23672888-0236-01

All 135 Dexamethasone NDCs

Other NDCs under ANDA 084612

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

FDA NDC Directory listings under ANDA 084612
ProductStrengthForm · routeLabelerProduct NDC
DexamethasoneDexamethasone 2 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-4183
DexamethasoneDexamethasone 1.5 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8181
DexamethasoneDexamethasone 4 mg/1TabletOralGolden State Medical Supply, Inc.51407-361
DexamethasoneDexamethasone 4 mg/1TabletOralREMEDYREPACK INC.70518-1534
DexamethasoneDexamethasone 4 mg/1TabletOralCardinal Health 107, LLC55154-4901
DexamethasoneDexamethasone .5 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8179
DexamethasoneDexamethasone 1 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-4181
DexamethasoneDexamethasone 4 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8175
DexamethasoneDexamethasone .5 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-4179
DexamethasoneDexamethasone 4 mg/1TabletOralDirect Rx72189-254
DexamethasoneDexamethasone 4 mg/1TabletOralProficient Rx LP63187-561
DexamethasoneDexamethasone 4 mg/1TabletOralDoc Rx69306-114
DexamethasoneDexamethasone 6 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8183
DexamethasoneDexamethasone .75 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8180
DexamethasoneDexamethasone 1.5 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-4182
DexamethasoneDexamethasone 4 mg/1TabletOralBryant Ranch Prepack63629-3742
DexamethasoneDexamethasone 4 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-582
DexamethasoneDexamethasone 4 mg/1TabletOralNorthwind Health Company, LLC51655-012
DexamethasoneDexamethasone 2 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-8176
DexamethasoneDexamethasone .75 mg/1TabletOralHikma Pharmaceuticals USA, Inc.0054-4180

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