NDC codes

FDA NDC Directory
Product NDC (as listed)70700-312Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0312Add 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
70700-312-8770700031287707000312871 POUCH in 1 CARTON (70700-312-87) / 1 BLISTER PACK in 1 POUCH / 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)
Rosyrah
Generic name (nonproprietary)
levonorgestrel and ethinyl estradiol and ethinyl estradiol
Dosage form
Kit
Route
Oral
Labeler
Xiromed, LLCNDC labeler code 70700
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206053
Marketing start
Listing expires
Identifiers
Product ID 70700-312_4fb6f740-69bf-590d-4474-43ff5c2e5986SPL ID 4fb6f740-69bf-590d-4474-43ff5c2e5986SPL set ID d2f0af55-205f-df9c-c572-1f7b14976655RxCUI 238019, 248310, 1373501, 1373502, 1373503, 2705814UPC 0370700312872

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

N470700031287 followed by a unit qualifier and the quantity

Package 70700-0312-87. 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)

Rosyrah is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Rosyrah is indicated for use by females of reproductive age to prevent pregnancy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70700-312

What is NDC 70700-312?
70700-312 is the product NDC for Rosyrah 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?
Rosyrah (Levonorgestrel and ethinyl estradiol and ethinyl estradiol).
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 Rosyrah?
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 206053

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

FDA NDC Directory listings under ANDA 206053
ProductStrengthForm · routeLabelerProduct NDC
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol—KitMylan Pharmaceuticals Inc.0378-7316

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