What is NDC 64380-785?

64380-785 is the product NDC for prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

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 prednisone?

280 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

prednisone NDC 64380-785 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-785Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0785Add 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 NDC	11-digit (billing)	Package
64380-785-01	64380078501	10 BLISTER PACK in 1 CARTON (64380-785-01) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2021
64380-785-06	64380078506	100 TABLET in 1 BOTTLE, PLASTIC (64380-785-06)Marketed from Sep 1, 2021
64380-785-07	64380078507	500 TABLET in 1 BOTTLE, PLASTIC (64380-785-07)Marketed from Sep 1, 2021
64380-785-08	64380078508	1000 TABLET in 1 BOTTLE, PLASTIC (64380-785-08)Marketed from Sep 1, 2021

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): prednisone
Generic name (nonproprietary): prednisone
Active ingredients: Prednisone — 20 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 208412
Marketing start: Sep 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 64380-785_bdf0b63b-7d6e-4799-be31-cdbf94e02145SPL ID bdf0b63b-7d6e-4799-be31-cdbf94e02145SPL set ID 2ef05381-faad-4e0f-b58d-9f2236a04a2cRxCUI 198145, 198148, 312615UNII VB0R961HZTUPC 0364380949060, 0364380785064, 0364380784067
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

N464380078501 followed by a unit qualifier and the quantity

Package 64380-0785-01. 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 Dec 15, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisone tablets USP are indicated in the following conditions: 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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 cas…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-785

What is NDC 64380-785?: 64380-785 is the product NDC for prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: prednisone.
What is the active ingredient?: Prednisone.
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 prednisone?: 280 other product NDCs are listed under this name. See all prednisone 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 prednisone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
PredniSONE	Prednisone 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4182	68788-4182-0168788-4182-0268788-4182-03+3 more
prednisone	Prednisone 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-069	87441-0069-01
prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1171	67046-1171-03
prednisone	Prednisone 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2582	55154-2582-00
prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4660	70518-4660-00
Prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1379	67046-1379-03
Prednisone	Prednisone 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2581	55154-2581-00
Prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4560	70518-4560-00
prednisone	Prednisone 5 mg/1	TabletOral	American Health Packaging	60687-903	60687-0903-01
prednisone	Prednisone 5 mg/1	TabletOral	Coupler LLC	67046-1642	67046-1642-03

All 281 prednisone NDCs

Other NDCs under ANDA 208412

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

FDA NDC Directory listings under ANDA 208412
Product	Strength	Form · route	Labeler	Product NDC
prednisone	Prednisone 10 mg/1	TabletOral	QPharma Inc	42708-166
prednisone	Prednisone 5 mg/1	TabletOral	QPharma Inc	42708-186
prednisone	Prednisone 20 mg/1	TabletOral	Medsource Pharmaceuticals	45865-884
prednisone	Prednisone 50 mg/1	TabletOral	A-S Medication Solutions	50090-6376
prednisone	Prednisone 10 mg/1	TabletOral	A-S Medication Solutions	50090-7218
prednisone	Prednisone 10 mg/1	TabletOral	A-S Medication Solutions	50090-7219
prednisone	Prednisone 5 mg/1	TabletOral	A-S Medication Solutions	50090-7505
prednisone	Prednisone 20 mg/1	TabletOral	A-S Medication Solutions	50090-8051
prednisone	Prednisone 20 mg/1	TabletOral	A-S Medication Solutions	50090-8052
prednisone	Prednisone 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-349
prednisone	Prednisone 20 mg/1	TabletOral	Northwind Health Company, LLC	51655-541
prednisone	Prednisone 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-972
Prednisone	Prednisone 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2581
prednisone	Prednisone 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2582
Prednisone	Prednisone 50 mg/1	TabletOral	American Health Packaging	60687-854
prednisone	Prednisone 5 mg/1	TabletOral	American Health Packaging	60687-903
Prednisone	Prednisone 10 mg/1	TabletOral	American Health Packaging	60687-914
Prednisone	Prednisone 20 mg/1	TabletOral	American Health Packaging	60687-925
prednisone	Prednisone 20 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-790
prednisone	Prednisone 5 mg/1	TabletOral	Strides Pharma Science Limited	64380-783

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