What is NDC 0378-7292?

0378-7292 is the product NDC for Norethindrone, Norethindrone .35 mg/1 tablet, 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 Norethindrone?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Norethindrone NDC 0378-7292 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7292Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7292Add 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
0378-7292-53	0037872925300378729253	3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 28 TABLET in 1 BLISTER PACKMarketed from Jul 12, 2013

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): Norethindrone
Generic name (nonproprietary): norethindrone
Active ingredients: Norethindrone — .35 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201483
Marketing start: Jul 12, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0378-7292_952f8023-4a5f-746d-c678-388b50e8909cSPL ID 952f8023-4a5f-746d-c678-388b50e8909cSPL set ID af851d82-b30f-463b-9dba-0437225dc1eeRxCUI 198042, 748961UNII T18F433X4S
Pharmacologic class: Progestin

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

N400378729253 followed by a unit qualifier and the quantity

Package 00378-7292-53. 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 Oct 23, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. Emergency Contraceptive Pills: Treatment initia…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7292

What is NDC 0378-7292?: 0378-7292 is the product NDC for Norethindrone, Norethindrone .35 mg/1 tablet, 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?: Norethindrone.
What is the active ingredient?: Norethindrone.
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 Norethindrone?: 5 other product NDCs are listed under this name. See all Norethindrone 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 Norethindrone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Norethindrone	Norethindrone .35 mg/1	TabletOral	A-S Medication Solutions	50090-6161	50090-6161-00
Norethindrone	Norethindrone .35 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-876	68180-0876-73
Norethindrone	Norethindrone .35 mg/1	TabletOral	Proficient Rx LP	82804-175	82804-0175-28
Norethindrone	Norethindrone .35 mg/1	TabletOral	Proficient Rx LP	63187-748	63187-0748-28
Norethindrone	Norethindrone .35 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-305	68462-0305-29

Other NDCs under ANDA 201483

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

FDA NDC Directory listings under ANDA 201483
Product	Strength	Form · route	Labeler	Product NDC
Orquideanorethindrone	Norethindrone .35 mg/1	TabletOral	Xiromed, LLC	70700-316