NDC codes

FDA NDC Directory
Product NDC (as listed)0069-1975Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00069-1975Add 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
0069-1975-40000691975404 CARTON in 1 CARTON (0069-1975-40) / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12)Marketed from May 16, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Vyndaqel
Generic name (nonproprietary)
tafamidis meglumine
Active ingredients
Tafamidis meglumine — 20 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 211996
Marketing start
Marketing end
Identifiers
Product ID 0069-1975_67f1031d-c298-4cf9-9051-bb8f99e56442SPL ID 67f1031d-c298-4cf9-9051-bb8f99e56442SPL set ID 1b4121ee-a733-4456-a917-be2603477839RxCUI 2168534, 2168540, 2168542, 2168548UNII ZU7CF08A1A, 8FG9H9D31J

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

N400069197540 followed by a unit qualifier and the quantity

Package 00069-1975-40. 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)

1. INDICATIONS AND USAGE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0069-1975

What is NDC 0069-1975?
0069-1975 is the product NDC for Vyndaqel (tafamidis meglumine), Tafamidis meglumine 20 mg/1 capsule, liquid filled, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Vyndaqel (Tafamidis meglumine).
What is the active ingredient?
Tafamidis meglumine.
Who is the labeler?
Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vyndaqel?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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