What is NDC 0555-0211?

0555-0211 is the product NDC for Norethindrone Acetate, Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 Acetate?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Norethindrone Acetate NDC 0555-0211

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-0211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-0211Add 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
0555-0211-10	0055502111000555021110	50 TABLET in 1 BOTTLE (0555-0211-10)Marketed from Jun 29, 2001

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 Acetate
Generic name (nonproprietary): norethindrone acetate
Active ingredients: Norethindrone acetate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075951
Marketing start: Jun 29, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0555-0211_953441f0-0a24-40ba-a433-1de55da3ebaaSPL ID 953441f0-0a24-40ba-a433-1de55da3ebaaSPL set ID f73f9807-4af6-4faa-ba9a-656a47a4c5e0RxCUI 1000405UNII 9S44LIC7OJ
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

N400555021110 followed by a unit qualifier and the quantity

Package 00555-0211-10. 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 Nov 30, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Norethindrone Acetate Tablets, USP are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone Acetate Tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0555-0211

What is NDC 0555-0211?: 0555-0211 is the product NDC for Norethindrone Acetate, Norethindrone acetate 5 mg/1 tablet, 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?: Norethindrone Acetate.
What is the active ingredient?: Norethindrone acetate.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 Acetate?: 6 other product NDCs are listed under this name. See all Norethindrone Acetate 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 Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	American Health Packaging	60687-921	60687-0921-21
Norethindrone acetate	Norethindrone acetate 5 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-267	50742-0267-50
Norethindrone Acetatenorethindrone	Norethindrone acetate 5 mg/1	TabletOral	AvKARE	42291-650	42291-0650-90
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-304	68462-0304-0568462-0304-50
Norethindrone Acetatenorethindrone	Norethindrone acetate 5 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-475	65162-0475-0365162-0475-0565162-0475-09+1 more
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-599	51407-0599-50

Other NDCs under ANDA 075951

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

FDA NDC Directory listings under ANDA 075951
Product	Strength	Form · route	Labeler	Product NDC
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-599