NDC codes

FDA NDC Directory
Product NDC (as listed)70700-306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0306Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70700-306-8570700030685707000306853 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, LLCNDC labeler code 70700
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

N470700030685 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 70700-306

What is NDC 70700-306?
70700-306 is the product NDC for Galbriela kit, listed with the FDA by Xiromed, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Galbriela (Norethindrone and ethinyl estradiol and ferrous fumarate).
Who is the labeler?
Xiromed, LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Galbriela?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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