NDC codes

FDA NDC Directory
Product NDC (as listed)51862-648Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51862-0648Add 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
51862-648-0151862064801518620648011 BLISTER PACK in 1 PACKET (51862-648-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020
51862-648-0251862064802518620648021 BLISTER PACK in 1 CARTON (51862-648-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020
51862-648-0351862064803518620648033 BLISTER PACK in 1 CARTON (51862-648-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020
51862-648-0651862064806518620648066 BLISTER PACK in 1 CARTON (51862-648-06) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020

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)
Microgestin 24 Fe
Generic name (nonproprietary)
norethindrone acetate/ethinyl estradiol and ferrous fumarate
Dosage form
Kit
Labeler
Mayne Pharma Inc.NDC labeler code 51862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202994
Marketing start
Listing expires
Identifiers
Product ID 51862-648_ae88cfe9-5fe5-4192-b174-91aa060cc3a3SPL ID ae88cfe9-5fe5-4192-b174-91aa060cc3a3SPL set ID 77b9fd75-25cd-4fbc-ab32-f3857d7e2b08RxCUI 259176, 1358762, 1359117, 1721965

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

N451862064801 followed by a unit qualifier and the quantity

Package 51862-0648-01. 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)

Microgestin 24 Fe is a progestin/estrogen COC indicated for use by women to prevent pregnancy. (1) The efficacy of Microgestin 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Microgestin 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Microgestin 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-648

What is NDC 51862-648?
51862-648 is the product NDC for Microgestin 24 Fe kit, listed with the FDA by Mayne Pharma Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Microgestin 24 Fe (Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate).
Who is the labeler?
Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Microgestin 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 202994

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

FDA NDC Directory listings under ANDA 202994
ProductStrengthForm · routeLabelerProduct NDC
Larin 24 Fenorethindrone acetate/ethinyl estradiol and ferrous fumarate—KitNorthstar Rx LLC16714-416

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