Prescription drug · ANDA
Sprintec (Norgestimate and ethinyl estradiol) NDC 0555-9016
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9016-58 | 00555901658 | 6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Sep 26, 2002 |
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)
- Sprintec
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075804
- Marketing start
- Listing expires
- Identifiers
- Product ID 0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150SPL ID a12a68e8-a8fe-4ce5-aa31-b3366c470150SPL set ID d9252820-131a-4870-8b11-945d1bfd5659RxCUI 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
N400555901658followed by a unit qualifier and the quantityPackage 00555-9016-58. 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 ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential 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 0555-9016
- What is NDC 0555-9016?
- 0555-9016 is the product NDC for 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?
- Sprintec (Norgestimate and Ethinyl Estradiol).
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 | 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 | Proficient Rx LP | 63187-911 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Preferred Pharmaceuticals, Inc. | 68788-7429 |