What is NDC 0093-3304?

0093-3304 is the product NDC for Reclipsen 28 Day kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Reclipsen 28 Day (Desogestrel and Ethinyl Estradiol).

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Reclipsen 28 Day?

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.

Reclipsen 28 Day NDC 0093-3304 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-3304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-3304Add 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
0093-3304-16	0009333041600093330416	6 POUCH in 1 CARTON (0093-3304-16) / 1 BLISTER PACK in 1 POUCH (0093-3304-28) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2017

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): Reclipsen 28 DaySuffix: 28 Day
Generic name (nonproprietary): desogestrel and ethinyl estradiol
Dosage form: Kit
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075256
Marketing start: Jan 1, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 0093-3304_6b24007e-0560-443d-9bca-894487c931afSPL ID 6b24007e-0560-443d-9bca-894487c931afSPL set ID a1e00bc6-7487-4057-9dcc-d0e2327d1d12RxCUI 240707, 748797, 749848, 753543

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

N400093330416 followed by a unit qualifier and the quantity

Package 00093-3304-16. 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 Jan 4, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Reclipsen™ (desogestrel and ethinyl estradiol tablets USP) 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-3304

What is NDC 0093-3304?: 0093-3304 is the product NDC for Reclipsen 28 Day kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Reclipsen 28 Day (Desogestrel and Ethinyl Estradiol).
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Reclipsen 28 Day?: 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 075256

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

FDA NDC Directory listings under ANDA 075256
Product	Strength	Form · route	Labeler	Product NDC
Apri 28 Daydesogestrel and ethinyl estradiol	—	Kit	Teva Pharmaceuticals USA, Inc.	0555-9043
Apri 28 Daydesogestrel and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-2481

Reclipsen 28 Day (Desogestrel and ethinyl estradiol) NDC 0093-3304