NDC codes

FDA NDC Directory
Product NDC (as listed)72657-108Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72657-0108Add 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
72657-108-1272657010812726570108121 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACKMarketed from Jul 29, 2022

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)
SheWise
Generic name (nonproprietary)
levonorgestrel
Active ingredients
Levonorgestrel — 1.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
GLENMARK THERAPEUTICS INC., USANDC labeler code 72657
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207044
Marketing start
Listing expires
Other FDA classes
Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers
Product ID 72657-108_6762d7cd-be6a-412c-961c-0864b2483cebSPL ID 6762d7cd-be6a-412c-961c-0864b2483cebSPL set ID 7be13a7e-b4ff-4fe1-82a6-f9914596d72aRxCUI 483325, 2730936UNII 5W7SIA7YZWUPC 0372657108126
Pharmacologic class
Progestin; Progestin-containing Intrauterine System

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472657010812 followed by a unit qualifier and the quantity

Package 72657-0108-12. 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 .

Indications (excerpt from the label)

Indications Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72657-108

What is NDC 72657-108?
72657-108 is the product NDC for SheWise (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by GLENMARK THERAPEUTICS INC., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
SheWise (Levonorgestrel).
What is the active ingredient?
Levonorgestrel.
Who is the labeler?
GLENMARK THERAPEUTICS INC., USA, NDC labeler code 72657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for SheWise?
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 207044

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

FDA NDC Directory listings under ANDA 207044
ProductStrengthForm · routeLabelerProduct NDC
LevonorgestrelLevonorgestrel 1.5 mg/1TabletOralGLENMARK THERAPEUTICS INC., USA72657-123
LevonorgestrelLevonorgestrel 1.5 mg/1TabletOralYYBA Corp73581-217
PostDay One-SteplevonorgestrelLevonorgestrel 1.5 mg/1TabletOralHome Health Brands, LLC85506-100

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