Tacrolimus NDC 16729-422

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0422Add 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
16729-422-01	16729042201	1 TUBE in 1 CARTON (16729-422-01) / 100 g in 1 TUBEMarketed from Jun 5, 2019
16729-422-10	16729042210	1 TUBE in 1 CARTON (16729-422-10) / 30 g in 1 TUBEMarketed from May 31, 2019
16729-422-12	16729042212	1 TUBE in 1 CARTON (16729-422-12) / 60 g in 1 TUBEMarketed from May 31, 2019

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): Tacrolimus
Generic name (nonproprietary): tacrolimus
Active ingredients: Tacrolimus — 1 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211688
Marketing start: May 31, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 16729-422_23a804e6-2854-6b9b-e063-6394a90af669SPL ID 23a804e6-2854-6b9b-e063-6394a90af669SPL set ID 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15RxCUI 313189, 314266UNII WM0HAQ4WNM
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

N416729042201 followed by a unit qualifier and the quantity

Package 16729-0422-01. 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 Oct 4, 2024. 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 211688

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

FDA NDC Directory listings under ANDA 211688
Product	Strength	Form · route	Labeler	Product NDC
Tacrolimus	Tacrolimus .3 mg/g	OintmentTopical	Accord Healthcare Inc.	16729-421