Tacrolimus NDC 0168-0416

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0416Add 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
0168-0416-30	00168041630	1 TUBE in 1 CARTON (0168-0416-30) / 30 g in 1 TUBEMarketed from Sep 9, 2014
0168-0416-60	00168041660	1 TUBE in 1 CARTON (0168-0416-60) / 60 g in 1 TUBEMarketed from Sep 9, 2014
0168-0416-99	00168041699	1 TUBE in 1 CARTON (0168-0416-99) / 100 g in 1 TUBEMarketed from Sep 9, 2014

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): Tacrolimus
Generic name (nonproprietary): tacrolimus
Active ingredients: Tacrolimus — 1 mg/g
Dosage form: Ointment
Route: Topical
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200744
Marketing start: Sep 9, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 0168-0416_a63cc4f4-5aba-4e02-915a-5535f2b625aaSPL ID a63cc4f4-5aba-4e02-915a-5535f2b625aaSPL set ID 1bf44a84-14fd-4f80-ad8a-99b1431d631fRxCUI 313189, 314266UNII WM0HAQ4WNMUPC 0301680417608, 0301680416601
Pharmacologic class: Calcineurin Inhibitor Immunosuppressant

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400168041630 followed by a unit qualifier and the quantity

Package 00168-0416-30. 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 Jan 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING , WARNINGS and PRECAUTIONS: Pediatric Use ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200744

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

FDA NDC Directory listings under ANDA 200744
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .3 mg/g	OintmentTopical	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0417