Pomalidomide NDC 59651-197

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0197Add 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
59651-197-01	59651019701	100 CAPSULE in 1 BOTTLE (59651-197-01)Marketed from Oct 30, 2020
59651-197-21	59651019721	21 CAPSULE in 1 BOTTLE (59651-197-21)Marketed from Oct 30, 2020

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): Pomalidomide
Generic name (nonproprietary): pomalidomide
Active ingredients: Pomalidomide — 4 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210249
Marketing start: Oct 30, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 59651-197_1539fbf9-8281-4c7b-827b-9f53b50d9042SPL ID 1539fbf9-8281-4c7b-827b-9f53b50d9042SPL set ID 1539fbf9-8281-4c7b-827b-9f53b50d9042RxCUI 1369718, 1369726, 1369730, 1369734UNII D2UX06XLB5
Pharmacologic class: Thalidomide Analog

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

N459651019701 followed by a unit qualifier and the quantity

Package 59651-0197-01. 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 Jan 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ). with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210249

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

FDA NDC Directory listings under ANDA 210249
Product	Strength	Form · route	Labeler	Product NDC
Pomalidomide	Pomalidomide 2 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-195
Pomalidomide	Pomalidomide 1 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-194
Pomalidomide	Pomalidomide 3 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-196