Prescription drug · ANDA
Tri-Sprintec (Norgestimate and ethinyl estradiol) NDC 68788-6325
Kit · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-6325-2 | 68788632502 | 1 BLISTER PACK in 1 POUCH (68788-6325-2) / 1 KIT in 1 BLISTER PACKMarketed from Oct 18, 2016 |
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-Sprintec
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075808
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-6325_fa13b024-d1c8-4a31-b78e-7d90e9a1229fSPL ID fa13b024-d1c8-4a31-b78e-7d90e9a1229fSPL set ID 1f8b9aad-f31f-4cda-861d-c08a977fc923RxCUI 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
N468788632502followed by a unit qualifier and the quantityPackage 68788-6325-02. 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-Sprintec ® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. () Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. () 1.1 Oral Contraceptive Tri-Sprintec ® (norgestimate and …
Excerpt only. Read the full label for complete information.
About NDC 68788-6325
- What is NDC 68788-6325?
- 68788-6325 is the product NDC for Tri-Sprintec kit, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 | Teva Pharmaceuticals USA, Inc. | 0555-9018 | 00555-9018-58 |
| Tri-Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-458 | 63187-0458-28 |
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 | Proficient Rx LP | 63187-458 |