Prescription drug · ANDA
Tri-Lo-Sprintec (Norgestimate and ethinyl estradiol) NDC 0093-2140
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-2140-62 | 00093214062 | 3 POUCH in 1 CARTON (0093-2140-62) / 1 BLISTER PACK in 1 POUCH (0093-2140-28) / 1 KIT in 1 BLISTER PACKMarketed from Dec 30, 2015 |
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)
- Tri-Lo-Sprintec
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076784
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-2140_204ad27b-376e-4d07-bf27-1db57f446045SPL ID 204ad27b-376e-4d07-bf27-1db57f446045SPL set ID ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cbRxCUI 578732, 748797, 749155, 749156, 749157, 856467
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
N400093214062followed by a unit qualifier and the quantityPackage 00093-2140-62. 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-Sprintec ® (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-Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] .
Excerpt only. Read the full label for complete information.
About NDC 0093-2140
- What is NDC 0093-2140?
- 0093-2140 is the product NDC for Tri-Lo-Sprintec kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tri-Lo-Sprintec (Norgestimate and Ethinyl Estradiol).
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tri-Lo-Sprintec?
- 1 other product NDC are listed under this name. See all Tri-Lo-Sprintec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tri-Lo-Sprintec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tri-Lo-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-287 | 71205-0287-28 |
Other NDCs under ANDA 076784
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-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-287 |