What is NDC 46708-565?

46708-565 is the product NDC for Erlotinib Hydrochloride, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 Hydrochloride?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Erlotinib Hydrochloride NDC 46708-565

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-565Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0565Add 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
46708-565-30	4670805653046708056530	30 TABLET, FILM COATED in 1 BOTTLE (46708-565-30)Marketed from Jul 9, 2021
46708-565-90	4670805659046708056590	90 TABLET, FILM COATED in 1 BOTTLE (46708-565-90)Marketed from Jul 9, 2021

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 Hydrochloride
Generic name (nonproprietary): erlotinib hydrochloride
Active ingredients: Erlotinib hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214719
Marketing start: Jul 9, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 46708-565_966e67f7-6259-4b1c-8c6a-b2589d57e1edSPL ID 966e67f7-6259-4b1c-8c6a-b2589d57e1edSPL set ID ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6bRxCUI 603203, 603206, 603208UNII DA87705X9KUPC 0346708567309, 0346708566302, 0346708565305
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

N446708056530 followed by a unit qualifier and the quantity

Package 46708-0565-30. 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 10, 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 has not been established in patients with NSCLC whose tumors have…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-565

What is NDC 46708-565?: 46708-565 is the product NDC for Erlotinib Hydrochloride, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Erlotinib Hydrochloride.
What is the active ingredient?: Erlotinib hydrochloride.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 Hydrochloride?: 8 other product NDCs are listed under this name. See all Erlotinib Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Erlotinib Hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-566	46708-0566-3046708-0566-90
Erlotinib Hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-567	46708-0567-3046708-0567-90
Erlotinib Hydrochloride	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-565	62332-0565-3062332-0565-90
Erlotinib Hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-566	62332-0566-3062332-0566-90
Erlotinib Hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-567	62332-0567-3062332-0567-90
Erlotinib Hydrochloride	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-080	72205-0080-30
Erlotinib Hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-081	72205-0081-30
Erlotinib Hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-082	72205-0082-30

Other NDCs under ANDA 214719

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

FDA NDC Directory listings under ANDA 214719
Product	Strength	Form · route	Labeler	Product NDC
Erlotinib Hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-566
Erlotinib Hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-567
Erlotinib Hydrochloride	Erlotinib hydrochloride 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-565
Erlotinib Hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-566
Erlotinib Hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-567