NDC codes

FDA NDC Directory
Product NDC (as listed)31722-781Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0781Add 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
31722-781-3031722078130317220781301 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2026

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)
Afatinib
Generic name (nonproprietary)
afatinib
Active ingredients
Afatinib dimaleate — 20 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 210750
Marketing start
Listing expires
Other FDA classes
Protein Kinase Inhibitors (Mechanism)
Identifiers
Product ID 31722-781_5a8ec67a-afb9-4b6b-e063-6394a90adfc6SPL ID 5a8ec67a-afb9-4b6b-e063-6394a90adfc6SPL set ID ec5b9e00-3eab-4dbd-9bb3-75865b1af485RxCUI 1430446, 1430451, 1430455UNII V1T5K7RZ0BUPC 0331722781305, 0331722783309, 0331722782302
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

N431722078130 followed by a unit qualifier and the quantity

Package 31722-0781-30. 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 .

Indications (excerpt from the label)

Afatinib tablets are a kinase inhibitor indicated for: • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) • Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 ) 1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer Afatinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung canc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-781

What is NDC 31722-781?
31722-781 is the product NDC for Afatinib, Afatinib dimaleate 20 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?
Afatinib.
What is the active ingredient?
Afatinib dimaleate.
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 Afatinib?
2 other product NDCs are listed under this name. See all Afatinib 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 Afatinib NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AfatinibAfatinib dimaleate 30 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-78231722-0782-30
AfatinibAfatinib dimaleate 40 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-78331722-0783-30

Other NDCs under ANDA 210750

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

FDA NDC Directory listings under ANDA 210750
ProductStrengthForm · routeLabelerProduct NDC
AfatinibAfatinib dimaleate 30 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-782
AfatinibAfatinib dimaleate 40 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-783

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in