What is NDC 70771-1521?

70771-1521 is the product NDC for Erlotinib, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Erlotinib?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Erlotinib NDC 70771-1521 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1521Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1521Add 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
70771-1521-3	7077115210370771152103	30 TABLET, FILM COATED in 1 BOTTLE (70771-1521-3)Marketed from Apr 30, 2020
70771-1521-7	7077115210770771152107	3 BLISTER PACK in 1 CARTON (70771-1521-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1521-2)Marketed from Apr 30, 2020
70771-1521-9	7077115210970771152109	90 TABLET, FILM COATED in 1 BOTTLE (70771-1521-9)Marketed from Apr 30, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Erlotinib
Generic name (nonproprietary): erlotinib
Active ingredients: Erlotinib hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213065
Marketing start: Apr 30, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 70771-1521_9d253beb-cd1f-45df-9b23-c521269d419fSPL ID 9d253beb-cd1f-45df-9b23-c521269d419fSPL set ID daaa1329-3a3f-439c-b13d-b301daa234d4RxCUI 603203, 603206, 603208UNII DA87705X9K
Pharmacologic class: Kinase Inhibitor

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

N470771152103 followed by a unit qualifier and the quantity

Package 70771-1521-03. 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 Nov 28, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1521

What is NDC 70771-1521?: 70771-1521 is the product NDC for Erlotinib, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Erlotinib.
What is the active ingredient?: Erlotinib hydrochloride.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Erlotinib?: 20 other product NDCs are listed under this name. See all Erlotinib 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 Erlotinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Erlotinib	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-263	31722-0263-30
Erlotinib	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-264	31722-0264-30
Erlotinib	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-265	31722-0265-30
Erlotinib	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-530	59651-0530-0359651-0530-10
Erlotinib	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-531	59651-0531-0359651-0531-10
Erlotinib	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-532	59651-0532-0359651-0532-10
Erlotinib	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-7662	00093-7662-56
Erlotinib	Erlotinib hydrochloride 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-913	68382-0913-0668382-0913-1668382-0913-84
Erlotinib	Erlotinib hydrochloride 100 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-914	68382-0914-0668382-0914-1668382-0914-84
Erlotinib	Erlotinib hydrochloride 150 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-915	68382-0915-0668382-0915-1668382-0915-84

All 21 Erlotinib NDCs

Other NDCs under ANDA 213065

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

FDA NDC Directory listings under ANDA 213065
Product	Strength	Form · route	Labeler	Product NDC
Erlotinib	Erlotinib hydrochloride 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-913
Erlotinib	Erlotinib hydrochloride 100 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-914
Erlotinib	Erlotinib hydrochloride 150 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-915
Erlotinib	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1522
Erlotinib	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1523