Prescription drug · ANDA
Tri-Sprintec (Norgestimate and ethinyl estradiol) NDC 63187-458
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-458-28 | 63187045828 | 6 POUCH in 1 CARTON (63187-458-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 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)
- Tri-Sprintec
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075808
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-458_5248afaf-9c38-4cc2-a25b-53d93491f698SPL ID 5248afaf-9c38-4cc2-a25b-53d93491f698SPL set ID c1fc22e5-e02d-4dda-a9ac-c592e922c467RxCUI 240128, 406396, 687424, 748797, 749784, 762333
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
N463187045828followed by a unit qualifier and the quantityPackage 63187-0458-28. 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)
INDICATIONS AND USAGE Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) 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-Sprintec (norgestimate and ethinyl estradiol tablets USP) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Tabl…
Excerpt only. Read the full label for complete information.
About NDC 63187-458
- What is NDC 63187-458?
- 63187-458 is the product NDC for Tri-Sprintec kit, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tri-Sprintec (Norgestimate and ethinyl estradiol).
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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-Sprintec?
- 2 other product NDCs are listed under this name. See all Tri-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-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-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Preferred Pharmaceuticals Inc. | 68788-6325 | 68788-6325-02 |
| Tri-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9018 | 00555-9018-58 |
Other NDCs under ANDA 075808
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-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9018 |
| Tri-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Preferred Pharmaceuticals Inc. | 68788-6325 |