Prescription drug · ANDA
Galbriela NDC 70700-306
norethindrone and ethinyl estradiol and ferrous fumarate · Kit · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-306-85 | 70700030685 | 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACKMarketed from Jan 29, 2025 |
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)
- Galbriela
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203371
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-306_8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5SPL ID 8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5SPL set ID 47465e7e-64f2-690b-166e-0e1c3e5bec7aRxCUI 1095223, 1099638, 1607990, 2704559UPC 0370700306857
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
N470700030685followed by a unit qualifier and the quantityPackage 70700-0306-85. 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)
Galbriela (norethindrone and ethinyl estradiol chewable tablet and ferrous fumarate chewable tablet) is indicated for use by women to prevent pregnancy. The efficacy of Galbriela in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Galbriela is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) The efficacy in females of reproductive potential with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.