Prescription drug · ANDA
Tri-Lo- Estarylla NDC 70700-120
norgestimate and ethinyl estradiol · Kit · Xiromed, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-120-85 | 70700012085 | 3 BLISTER PACK in 1 CARTON (70700-120-85) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023 |
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)
- Tri-Lo- Estarylla
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Xiromed, LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091232
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-120_b2a112e8-a8c4-2254-1046-9ee6263e66e1SPL ID b2a112e8-a8c4-2254-1046-9ee6263e66e1SPL set ID 8381db98-f9b2-e894-c07e-5d49f10e4eeaRxCUI 578732, 748797, 749155, 749156, 749157, 1722676
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
N470700012085followed by a unit qualifier and the quantityPackage 70700-0120-85. 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)
Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ].
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091232
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tri-Lo- Estaryllanorgestimate and ethinyl estradiol | — | Kit | Bryant Ranch Prepack | 63629-2351 |
| Norgestimate and Ethinyl Estradiol | — | Kit | AvKARE | 42291-565 |