What is NDC 0378-7300?

0378-7300 is the product NDC for Drospirenone And Ethinyl Estradiol kit, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Drospirenone And Ethinyl Estradiol?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Drospirenone And Ethinyl Estradiol NDC 0378-7300

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7300Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7300Add 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
0378-7300-53	0037873005300378730053	3 POUCH in 1 CARTON (0378-7300-53) / 1 BLISTER PACK in 1 POUCH (0378-7300-85) / 1 KIT in 1 BLISTER PACKMarketed from Aug 28, 2015

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): Drospirenone And Ethinyl Estradiol
Generic name (nonproprietary): drospirenone and ethinyl estradiol
Dosage form: Kit
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202131
Marketing start: Aug 28, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-7300_29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63fSPL ID 29e77a5a-0e9f-2c5b-efd5-2fbbd10ae63fSPL set ID 25f9b952-cc1d-454e-a3ec-834ba1774b6bRxCUI 284207, 748797, 748800

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

N400378730053 followed by a unit qualifier and the quantity

Package 00378-7300-53. 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 Sep 22, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are indicated for use by females of reproductive potential to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, 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)

About NDC 0378-7300

What is NDC 0378-7300?: 0378-7300 is the product NDC for Drospirenone And Ethinyl Estradiol kit, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Drospirenone And Ethinyl Estradiol.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Drospirenone And Ethinyl Estradiol?: 12 other product NDCs are listed under this name. See all Drospirenone And Ethinyl Estradiol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Drospirenone And Ethinyl Estradiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Drospirenone And Ethinyl Estradiol	—	Kit	Apotex Corp.	60505-4897	60505-4897-08
Drospirenone and Ethinyl Estradiol	—	Kit	NorthStar Rx LLC	72603-875	72603-0875-03
Drospirenone And Ethinyl Estradiol	—	Kit	Naari Pte. Limited	79929-019	79929-0019-07
Drospirenone And Ethinyl Estradiol	—	Kit	Redpharm Drug	67296-2286	67296-2286-03
Drospirenone And Ethinyl Estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-868	68180-0868-73
Drospirenone and Ethinyl Estradiol	—	Kit	Camber Pharmaceuticals, Inc.	31722-945	31722-0945-3131722-0945-32
Drospirenone and ethinyl estradiol	—	Kit	Camber Pharmaceuticals, Inc.	31722-934	31722-0934-3131722-0934-32
drospirenone and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-2494	50090-2494-00
drospirenone and ethinyl estradiol	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-733	68462-0733-29
drospirenone and ethinyl estradiol	—	Kit	A-S Medication Solutions	50090-2594	50090-2594-00

All 13 Drospirenone And Ethinyl Estradiol NDCs