Tyblume NDC 0642-7471

NDC codes

FDA NDC Directory

Product NDC (as listed)0642-7471Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00642-7471Add 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 NDC	11-digit (billing)	Package	Copy
0642-7471-01	00642747101	1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 26, 2020
0642-7471-02	00642747102	1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 26, 2020 · Sample package

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Tyblume
Generic name (nonproprietary): levonorgestrel and ethinyl estradiol
Dosage form: Kit
Labeler: Exeltis USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209405
Marketing start: Oct 26, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 0642-7471_5a0b1701-f165-fce7-e063-6294a90a8062SPL ID 5a0b1701-f165-fce7-e063-6294a90a8062SPL set ID b2482d51-d606-4aaa-8af4-19e4fe2f8872RxCUI 242297, 2465331, 2539224, 2539227, 2539228

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

N400642747101 followed by a unit qualifier and the quantity

Package 00642-7471-01. 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 Aug 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)