What is NDC 63304-096?

63304-096 is the product NDC for Erlotinib, Erlotinib 100 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 63304-096 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-096Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0096Add 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
63304-096-11	6330400961163304009611	3 BLISTER PACK in 1 CARTON (63304-096-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-096-31)Marketed from Nov 5, 2019
63304-096-30	6330400963063304009630	30 TABLET, FILM COATED in 1 BOTTLE (63304-096-30)Marketed from Nov 5, 2019

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): Erlotinib
Generic name (nonproprietary): erlotinib
Active ingredients: Erlotinib — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210300
Marketing start: Nov 5, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 63304-096_c160713b-c06f-49b4-80ea-fc1afb030b81SPL ID c160713b-c06f-49b4-80ea-fc1afb030b81SPL set ID e36fa076-e23b-437f-bbd2-0433ce333175RxCUI 603203, 603206, 603208UNII J4T82NDH7EUPC 0363304095302
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

N463304009611 followed by a unit qualifier and the quantity

Package 63304-0096-11. 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 Nov 6, 2019.

Indications (excerpt from the label)

Erlotinib tablets are kinase inhibitors indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1) • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2) Limitations of Use : • Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-096

What is NDC 63304-096?: 63304-096 is the product NDC for Erlotinib, Erlotinib 100 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Erlotinib.
What is the active ingredient?: Erlotinib.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 210300

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

FDA NDC Directory listings under ANDA 210300
Product	Strength	Form · route	Labeler	Product NDC
Erlotinib	Erlotinib 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	63304-095
Erlotinib	Erlotinib 150 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	63304-135