Prescription drug · ANDA
Sprintec (Norgestimate and ethinyl estradiol) NDC 63187-911
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-911-28 | 63187091128 | 1 BLISTER PACK in 1 POUCH (63187-911-28) / 1 KIT in 1 BLISTER PACKMarketed from Sep 1, 2017 |
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)
- 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 075804
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-911_cf674be7-f206-4b82-ab29-e9658b7f70a6SPL ID cf674be7-f206-4b82-ab29-e9658b7f70a6SPL set ID 4e1927bd-378d-45dc-8b18-3dd57ccd2cb6RxCUI 240128, 748797, 749860, 753481UPC 0363187911287
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
N463187091128followed by a unit qualifier and the quantityPackage 63187-0911-28. 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)
• Sprintec ® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 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( 14 )].
Excerpt only. Read the full label for complete information.
About NDC 63187-911
- What is NDC 63187-911?
- 63187-911 is the product NDC for 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?
- 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 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 | Preferred Pharmaceuticals, Inc. | 68788-7429 | 68788-7429-02 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9016 | 00555-9016-58 |
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 | Preferred Pharmaceuticals, Inc. | 68788-7429 |