NDC codes

FDA NDC Directory
Product NDC (as listed)70377-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0013Add 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
70377-013-11703770013117037700131130 TABLET in 1 BOTTLE (70377-013-11)Marketed from Jun 8, 2023
70377-013-2270377001322703770013224 BLISTER PACK in 1 CARTON (70377-013-22) / 7 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2021
70377-013-2370377001323703770013234 BLISTER PACK in 1 CARTON (70377-013-23) / 7 TABLET in 1 BLISTER PACKMarketed from May 17, 2024

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)
Everolimus
Generic name (nonproprietary)
everolimus
Active ingredients
Everolimus — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Biocon Pharma Inc.NDC labeler code 70377
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214182
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers
Product ID 70377-013_4e63b36e-3d75-b3b0-42b6-f2f3c1ddf4d0SPL ID 4e63b36e-3d75-b3b0-42b6-f2f3c1ddf4d0SPL set ID 5fb55800-f322-6bb6-9dde-622925ef28bdRxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6G
Pharmacologic class
Kinase Inhibitor; mTOR Inhibitor Immunosuppressant

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

N470377001311 followed by a unit qualifier and the quantity

Package 70377-0013-11. 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)

Everolimus tablets are kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer Ever…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70377-013

What is NDC 70377-013?
70377-013 is the product NDC for Everolimus, Everolimus 10 mg/1 tablet, listed with the FDA by Biocon Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Everolimus.
What is the active ingredient?
Everolimus.
Who is the labeler?
Biocon Pharma Inc., NDC labeler code 70377. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Everolimus?
65 other product NDCs are listed under this name. See all Everolimus 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 Everolimus NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EverolimusEverolimus .25 mg/1TabletOrali3 Pharmaceuticals, LLC72319-00372319-0003-0272319-0003-60
EverolimusEverolimus .5 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01572319-0015-0272319-0015-60
EverolimusEverolimus .75 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01672319-0016-0272319-0016-60
EverolimusEverolimus 1 mg/1TabletOrali3 Pharmaceuticals, LLC72319-01772319-0017-0272319-0017-60
everolimusEverolimus 7.5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03282293-0032-1082293-0032-2182293-0032-31
everolimusEverolimus 2.5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03082293-0030-1082293-0030-2182293-0030-31
everolimusEverolimus 5 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03182293-0031-1082293-0031-2182293-0031-31
everolimusEverolimus 10 mg/1TabletOralNovugen Pharma (USA) LLC.82293-03382293-0033-1082293-0033-2182293-0033-31
everolimusEverolimus .75 mg/1TabletOralAurobindo Pharma Limited59651-93359651-0933-60
everolimusEverolimus .25 mg/1TabletOralAurobindo Pharma Limited59651-93159651-0931-60

All 66 Everolimus NDCs

Other NDCs under ANDA 214182

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

FDA NDC Directory listings under ANDA 214182
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus 2.5 mg/1TabletOralBiocon Pharma Inc.70377-010
EverolimusEverolimus 5 mg/1TabletOralBiocon Pharma Inc.70377-011
EverolimusEverolimus 7.5 mg/1TabletOralBiocon Pharma Inc.70377-012
EverolimusEverolimus 2.5 mg/1TabletOralNorthStar RxLLC72603-254
EverolimusEverolimus 5 mg/1TabletOralNorthStar RxLLC72603-255
EverolimusEverolimus 7.5 mg/1TabletOralNorthStar RxLLC72603-256
EverolimusEverolimus 10 mg/1TabletOralNorthStar RxLLC72603-257
TorpenzeverolimusEverolimus 2.5 mg/1TabletOralUpsher-Smith Laboratories, LLC0245-0822
TorpenzeverolimusEverolimus 5 mg/1TabletOralUpsher-Smith Laboratories, LLC0245-0823
TorpenzeverolimusEverolimus 7.5 mg/1TabletOralUpsher-Smith Laboratories, LLC0245-0824
TorpenzeverolimusEverolimus 10 mg/1TabletOralUpsher-Smith Laboratories, LLC0245-0825

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