Prescription drug · ANDA
Norgestimate and Ethinyl Estradiol NDC 72789-434
Kit · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-434-79 | 72789043479 | 1 BLISTER PACK in 1 POUCH (72789-434-79) / 1 KIT in 1 BLISTER PACKMarketed from Oct 2, 2024 |
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)
- Norgestimate and Ethinyl Estradiol
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075804
- Marketing start
- Listing expires
- Identifiers
- Product ID 72789-434_3247501e-2fd5-720c-e063-6294a90a77d4SPL ID 3247501e-2fd5-720c-e063-6294a90a77d4SPL set ID 00dd9b78-dd90-414b-b241-7619aa9d1ed2RxCUI 240128, 748797, 749860UPC 0372789434797
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
N472789043479followed by a unit qualifier and the quantityPackage 72789-0434-79. 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.
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 |
|---|---|---|---|---|
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9016 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Preferred Pharmaceuticals, Inc. | 68788-7429 |
| Sprintecnorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-911 |