NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1031Add 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
69238-1031-769238103107692381031073 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6)Marketed from Sep 21, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Melodetta 24 Fe
Generic name (nonproprietary)
norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form
Kit
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207514
Marketing start
Listing expires
Identifiers
Product ID 69238-1031_ef7d6985-bc76-4ecc-9774-7edfacbef22cSPL ID ef7d6985-bc76-4ecc-9774-7edfacbef22cSPL set ID ca89a8e3-4df1-4e4b-9da7-0233770e542bRxCUI 259176, 1426288, 1426600, 1944656UPC 0369238103168, 0369238103175

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

N469238103107 followed by a unit qualifier and the quantity

Package 69238-1031-07. 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)

Melodetta™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Melodetta™ 24 Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1) The efficacy in women with a body mass index of more than 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 69238-1031

What is NDC 69238-1031?
69238-1031 is the product NDC for Melodetta 24 Fe kit, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Melodetta 24 Fe (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate).
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Melodetta 24 Fe?
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.

Other NDCs under ANDA 207514

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207514
ProductStrengthForm · routeLabelerProduct NDC
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate—KitAmneal Pharmaceuticals NY LLC60219-1031

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