NDC codes

FDA NDC Directory
Product NDC (as listed)64380-970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0970Add 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
64380-970-256438009702550 TABLET in 1 BOTTLE, PLASTIC (64380-970-25)Marketed from Sep 25, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Hydrocortisone
Generic name (nonproprietary)
hydrocortisone
Active ingredients
Hydrocortisone — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207029
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 64380-970_e31ab65b-eef6-4d60-98fe-e2150a130b9fSPL ID e31ab65b-eef6-4d60-98fe-e2150a130b9fSPL set ID 90a46849-5b75-467b-9bc5-8f192d4d20d2RxCUI 197782, 197783, 197787UNII WI4X0X7BPJUPC 0364380972068, 0364380971061, 0364380970255
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

N464380097025 followed by a unit qualifier and the quantity

Package 64380-0970-25. 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 Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-970

What is NDC 64380-970?
64380-970 is the product NDC for Hydrocortisone, Hydrocortisone 5 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone.
What is the active ingredient?
Hydrocortisone.
Who is the labeler?
Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocortisone?
169 other product NDCs are listed under this name. See all Hydrocortisone 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 Hydrocortisone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HydrocortisoneHydrocortisone 1 g/100gLotionTopicalAmazon.com Services LLC72288-46972288-0469-25
HydrocortisoneHydrocortisone 10 mg/1TabletOralSolco Healthcare LLC43547-89343547-0893-10
HydrocortisoneHydrocortisone 5 mg/1TabletOralSolco Healthcare LLC43547-89243547-0892-05
HydrocortisoneHydrocortisone 20 mg/1TabletOralSolco Healthcare LLC43547-89443547-0894-10
HydrocortisoneHydrocortisone 1 g/100gCreamTopicalAmazon.com Services LLC72288-71372288-0713-64
HydrocortisoneHydrocortisone 25 mg/gCreamTopicalEncube Ethicals, Inc.21922-06521922-0065-0521922-0065-30
HydrocortisoneHydrocortisone 20 mg/gGelTopicalRedmont Pharmaceuticals, LLC71741-45571741-0455-31
HydrocortisoneHydrocortisone 10 mg/gCreamTopicalSportpharm LLC85766-16685766-0166-1085766-0166-25
hydrocortisoneHydrocortisone 1 g/100gCreamTopicalSportpharm LLC85766-15185766-0151-28
Hydrocortisonehydrocortisone cream 1%Hydrocortisone 1 g/100gCreamTopicalAldermed Inc.87236-00487236-0004-09

All 170 Hydrocortisone NDCs

Other NDCs under ANDA 207029

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

FDA NDC Directory listings under ANDA 207029
ProductStrengthForm · routeLabelerProduct NDC
HydrocortisoneHydrocortisone 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-227
HydrocortisoneHydrocortisone 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-228
HydrocortisoneHydrocortisone 20 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-229
HydrocortisoneHydrocortisone 5 mg/1TabletOralAmerican Health Packaging60687-844
HydrocortisoneHydrocortisone 10 mg/1TabletOralAmerican Health Packaging60687-582
HydrocortisoneHydrocortisone 5 mg/1TabletOralChartwell RX, LLC.62135-551
HydrocortisoneHydrocortisone 10 mg/1TabletOralChartwell RX, LLC.62135-552
HydrocortisoneHydrocortisone 5 mg/1TabletOralStrides Pharma Inc.42543-970
HydrocortisoneHydrocortisone 5 mg/1TabletOralAsclemed USA, Inc.76420-110
HydrocortisoneHydrocortisone 10 mg/1TabletOralStrides Pharma Inc.42543-971
HydrocortisoneHydrocortisone 20 mg/1TabletOralStrides Pharma Inc.42543-972
HydrocortisoneHydrocortisone 10 mg/1TabletOralStrides Pharma Science Limited64380-971
HydrocortisoneHydrocortisone 20 mg/1TabletOralStrides Pharma Science Limited64380-972

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