What is NDC 70095-043?

70095-043 is the product NDC for Deflazacort, Deflazacort 36 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Deflazacort?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Deflazacort NDC 70095-043 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70095-043Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70095-0043Add 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	Copy
70095-043-30	7009500433070095004330	1 BOTTLE in 1 CARTON (70095-043-30) / 30 TABLET in 1 BOTTLEMarketed from Mar 19, 2025

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): Deflazacort
Generic name (nonproprietary): deflazacort
Active ingredients: Deflazacort — 36 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 70095
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217741
Marketing start: Mar 19, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 70095-043_4583474c-40e7-dd9d-e063-6294a90a902aSPL ID 4583474c-40e7-dd9d-e063-6294a90a902aSPL set ID fb5350d5-ead1-41f4-8b25-0da0bd7fcffeRxCUI 153098, 153880, 1870954, 1870958UNII KR5YZ6AE4BUPC 0370095040015, 0370095043306, 0370095042309, 0370095041302
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

N470095004330 followed by a unit qualifier and the quantity

Package 70095-0043-30. 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 9, 2025.

Indications (excerpt from the label)

Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Deflazacort tablets are corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70095-043

What is NDC 70095-043?: 70095-043 is the product NDC for Deflazacort, Deflazacort 36 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Deflazacort.
What is the active ingredient?: Deflazacort.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Deflazacort?: 31 other product NDCs are listed under this name. See all Deflazacort 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 Deflazacort NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Deflazacort	Deflazacort 6 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0824	00054-0824-25
Deflazacort	Deflazacort 18 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0825	00054-0825-13
Deflazacort	Deflazacort 30 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0826	00054-0826-13
Deflazacort	Deflazacort 36 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0827	00054-0827-13
Deflazacort	Deflazacort 6 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2282	60219-2282-01
Deflazacort	Deflazacort 18 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2283	60219-2283-01
Deflazacort	Deflazacort 30 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2284	60219-2284-01
Deflazacort	Deflazacort 36 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2285	60219-2285-01
Deflazacort	Deflazacort 6 mg/1	TabletOral	AvKARE	73190-068	73190-0068-01
Deflazacort	Deflazacort 18 mg/1	TabletOral	AvKARE	73190-069	73190-0069-30

All 32 Deflazacort NDCs

Other NDCs under ANDA 217741

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

FDA NDC Directory listings under ANDA 217741
Product	Strength	Form · route	Labeler	Product NDC
Deflazacort	Deflazacort 6 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	70095-040
Deflazacort	Deflazacort 18 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	70095-041
Deflazacort	Deflazacort 30 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	70095-042