NDC codes

FDA NDC Directory
Product NDC (as listed)43975-315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43975-0315Add 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
43975-315-1043975031510100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)Marketed from May 10, 2018

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)
Bexarotene
Generic name (nonproprietary)
bexarotene
Active ingredients
Bexarotene — 75 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 43975
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209861
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91SPL ID 07544503-a705-48cb-9a86-5bb5ece3fb91SPL set ID e713c60d-f623-4260-b0ca-db07e1365fd2RxCUI 308725UNII A61RXM4375UPC 0343975315107
Pharmacologic class
Retinoid

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

N443975031510 followed by a unit qualifier and the quantity

Package 43975-0315-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Bexarotene capsules are a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43975-315

What is NDC 43975-315?
43975-315 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, liquid filled, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bexarotene.
What is the active ingredient?
Bexarotene.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 43975. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bexarotene?
7 other product NDCs are listed under this name. See all Bexarotene 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 Bexarotene NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BexaroteneBexarotene 75 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-38031722-0380-01
BexaroteneBexarotene 75 mg/1CapsuleOralAvKARE42291-07242291-0072-01
BexaroteneBexarotene 10 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-208869238-2088-06
bexaroteneBexarotene 75 mg/1Capsule, Liquid filledOralActavis Pharma, Inc.0591-283200591-2832-01
BexaroteneBexarotene 75 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-125069238-1250-01
BexaroteneBexarotene 75 mg/1CapsuleOralUpsher-Smith Laboratories, Inc.0832-028500832-0285-00
BexaroteneBexarotene 75 mg/1Capsule, Liquid filledOralMylan Pharmaceuticals Inc.0378-695500378-6955-01

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