What is NDC 31722-263?

31722-263 is the product NDC for Erlotinib, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 31722-263 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0263Add 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
31722-263-30	3172202633031722026330	1 BOTTLE in 1 CARTON (31722-263-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from May 24, 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): Erlotinib
Generic name (nonproprietary): erlotinib
Active ingredients: Erlotinib hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209267
Marketing start: May 24, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 31722-263_1bca3db4-f885-5bed-e063-6294a90ae9faSPL ID 1bca3db4-f885-5bed-e063-6294a90ae9faSPL set ID a3b2d622-b4d5-4819-862b-f8fd3adcec6fRxCUI 603203, 603206, 603208UNII DA87705X9KUPC 0331722264303, 0331722265300, 0331722263306
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

N431722026330 followed by a unit qualifier and the quantity

Package 31722-0263-30. 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 Jun 26, 2024.

Indications (excerpt from the label)

Erlotinib tablets are a kinase inhibitor 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-263

What is NDC 31722-263?: 31722-263 is the product NDC for Erlotinib, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 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
Erlotinib	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1521	70771-1521-0370771-1521-0770771-1521-09

All 21 Erlotinib NDCs

Other NDCs under ANDA 209267

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

FDA NDC Directory listings under ANDA 209267
Product	Strength	Form · route	Labeler	Product NDC
Erlotinib	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-264
Erlotinib	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-265