NDC codes

FDA NDC Directory
Product NDC (as listed)16714-407Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0407Add 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
16714-407-01167140407011 BLISTER PACK in 1 PACKET (16714-407-01) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014
16714-407-02167140407021 BLISTER PACK in 1 CARTON (16714-407-02) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014
16714-407-03167140407033 BLISTER PACK in 1 CARTON (16714-407-03) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014
16714-407-04167140407046 BLISTER PACK in 1 CARTON (16714-407-04) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014

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)
Larin 1.5/30
Generic name (nonproprietary)
norethindrone acetate/ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202996
Marketing start
Listing expires
Identifiers
Product ID 16714-407_3136be5c-9efe-44d1-9e31-6f4ab797bfe4SPL ID 3136be5c-9efe-44d1-9e31-6f4ab797bfe4SPL set ID e232ed29-e6f5-4591-8d61-68eb8b1596f0RxCUI 1359022, 1359028, 1537209

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

N416714040701 followed by a unit qualifier and the quantity

Package 16714-0407-01. 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)

INDICATIONS AND USAGE LARIN™ 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. table1

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202996

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

FDA NDC Directory listings under ANDA 202996
ProductStrengthForm · routeLabelerProduct NDC
Microgestin 1.5/30norethindrone acetate/ethinyl estradiol—KitDr. Reddys Laboratories Inc.75907-083
Microgestin 1.5/30norethindrone acetate/ethinyl estradiol—KitMayne Pharma Inc.51862-872

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