Tri-Estarylla NDC 63629-2350

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2350Add 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
63629-2350-1	63629235001	3 BLISTER PACK in 1 CARTON (63629-2350-1) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Tri-Estarylla
Generic name (nonproprietary): norgestimate and ethinyl estradiol
Dosage form: Kit
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090793
Marketing start: Sep 1, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 63629-2350_74936d25-1b06-4b3b-9e6d-9ba409a060fcSPL ID 74936d25-1b06-4b3b-9e6d-9ba409a060fcSPL set ID 6560d15f-6ce9-4f0e-9b59-043dec35ddd9RxCUI 240128, 406396, 687424, 748797, 749784, 1369770

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N463629235001 followed by a unit qualifier and the quantity

Package 63629-2350-01. 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 May 21, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Estarylla (norgestimate and ethinyl estradiol) Tablets are indicated for use by females of reproductive potenti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090793

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

FDA NDC Directory listings under ANDA 090793
Product	Strength	Form · route	Labeler	Product NDC
Tri-Estaryllanorgestimate and ethinyl estradiol	—	Kit	Xiromed, LLC.	70700-121
norgestimate and ethinyl estradiol	—	Kit	AvKARE	42291-590
Tri-Estaryllanorgestimate and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-7861