Prescription drug · ANDA
Sprintec (Norgestimate and ethinyl estradiol) NDC 68788-7429
Kit · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7429-2 | 68788742902 | 1 BLISTER PACK in 1 POUCH (68788-7429-2) / 1 KIT in 1 BLISTER PACKMarketed from Oct 2, 2019 |
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)
- 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 075804
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-7429_1987d5a8-81aa-4240-918b-0ce3e2de1cf4SPL ID 1987d5a8-81aa-4240-918b-0ce3e2de1cf4SPL set ID 90240210-0bca-4a55-99dc-19f2b40d8e3fRxCUI 240128, 748797, 749860, 753481
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
N468788742902followed by a unit qualifier and the quantityPackage 68788-7429-02. 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)
Sprintec ® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. () 1.1 Oral Contraceptive Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ()].
Excerpt only. Read the full label for complete information.
About NDC 68788-7429
- What is NDC 68788-7429?
- 68788-7429 is the product NDC for 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?
- 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 Sprintec?
- 2 other product NDCs are listed under this name. See all Sprintec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9016 | 00555-9016-58 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-911 | 63187-0911-28 |
Other NDCs under ANDA 075804
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 |
|---|---|---|---|---|
| Norgestimate and Ethinyl Estradiol | — | Kit | PD-Rx Pharmaceuticals, Inc. | 72789-434 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9016 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-911 |