Balcoltra NDC 75854-602

NDC codes

FDA NDC Directory

Product NDC (as listed)75854-602Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75854-0602Add 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
75854-602-02	75854060202	2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACKMarketed from Apr 10, 2018
75854-602-03	75854060203	3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACKMarketed from Apr 10, 2018
75854-602-28	75854060228	1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACKMarketed from Apr 10, 2018

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): Balcoltra
Generic name (nonproprietary): levonorgestrel and ethinyl estradiol
Dosage form: Kit
Labeler: Avion Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208612
Marketing start: Apr 10, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 75854-602_57bb625e-d567-432d-a6c2-44b329de9b7bSPL ID 57bb625e-d567-432d-a6c2-44b329de9b7bSPL set ID 752ab698-4b48-4614-8016-d1d33ee7c007RxCUI 242297, 1999026, 2672922, 2672923

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

N475854060202 followed by a unit qualifier and the quantity

Package 75854-0602-02. 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 Dec 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy. Balcoltra is a progestin/estrogen COC 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)

Other NDCs under NDA 208612

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

FDA NDC Directory listings under NDA 208612
Product	Strength	Form · route	Labeler	Product NDC
levonorgestrel and ethinyl estradiol	—	Kit	Acella Pharmaceuticals	42192-623