What is NDC 59651-136?

59651-136 is the product NDC for Emzahh (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Emzahh?

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.

Emzahh NDC 59651-136 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-136Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0136Add 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
59651-136-28	5965101362859651013628	1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 6, 2023
59651-136-88	5965101368859651013688	3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCHMarketed from Jan 6, 2023
59651-136-92	5965101369259651013692	6 POUCH in 1 CARTON (59651-136-92) / 1 TABLET in 1 POUCHMarketed from Jan 6, 2023

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): Emzahh
Generic name (nonproprietary): norethindrone
Active ingredients: Norethindrone — .35 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216796
Marketing start: Jan 6, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 59651-136_b785dba5-f0b0-4f74-8845-e845432932c0SPL ID b785dba5-f0b0-4f74-8845-e845432932c0SPL set ID 197d31d3-eec8-49c7-9640-918ff138fea2RxCUI 198042, 748961, 2626828UNII 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

N459651013628 followed by a unit qualifier and the quantity

Package 59651-0136-28. 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 Apr 10, 2023.

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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: 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. Method (1) % of Women Experiencing an Unintended Pregnancy wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-136

What is NDC 59651-136?: 59651-136 is the product NDC for Emzahh (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Emzahh (Norethindrone).
What is the active ingredient?: Norethindrone.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Emzahh?: 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.

Emzahh (Norethindrone) NDC 59651-136