Prescription drug · ANDA
Norgestimate and ethinyl estradiol NDC 79929-009
Kit · Naari Pte Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79929-009-07 | 79929000907 | 3 CARTON in 1 CARTON (79929-009-07) / 1 KIT in 1 CARTONMarketed from Dec 31, 2022 |
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
- Naari Pte Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200383
- Marketing start
- Listing expires
- Identifiers
- Product ID 79929-009_16bd96e5-1150-09e4-e063-6294a90a138dSPL ID 16bd96e5-1150-09e4-e063-6294a90a138dSPL set ID b936a6fb-27ed-44de-9199-8c656bcd366eRxCUI 240128, 406396, 687424, 748797, 749784
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
N479929000907followed by a unit qualifier and the quantityPackage 79929-0009-07. 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)
Norgestimate and Ethinyl Estradiol Tablets USP are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1) Norgestimate and Ethinyl Estradiol Tablets USP 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. Norgestimate and Ethinyl Estradiol Tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2) 1.1 Oral Contraceptive Norgestimate and ethinyl estradiol tablets USP are indicated for u…
Excerpt only. Read the full label for complete information.