NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3327Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3327Add 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 NDC11-digit (billing)PackageCopy
50090-3327-0500903327001 TUBE, WITH APPLICATOR in 1 CARTON (50090-3327-0) / 42.5 g in 1 TUBE, WITH APPLICATORMarketed from Jan 11, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Estradiol
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .1 mg/g
Dosage form
Cream
Route
Vaginal
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 086069
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 50090-3327_61484e03-f4f1-4e80-b7f0-b0b1ce5a7866SPL ID 61484e03-f4f1-4e80-b7f0-b0b1ce5a7866SPL set ID c8a2d29c-299c-4559-b859-87b303a4af81RxCUI 310169UNII 4TI98Z838E
Pharmacologic class
Estrogen

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

N450090332700 followed by a unit qualifier and the quantity

Package 50090-3327-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estradiol vaginal cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-3327

What is NDC 50090-3327?
50090-3327 is the product NDC for Estradiol, Estradiol .1 mg/g cream, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Estradiol.
What is the active ingredient?
Estradiol.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Estradiol?
181 other product NDCs are listed under this name. See all 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 Estradiol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EstradiolEstradiol .75 mg/1.25gGelTransdermalEncube Ethicals, Inc.21922-01521922-0015-40
EstradiolEstradiol .75 mg/1.25gGelTopicalSolaris Pharma Corporation73473-30873473-0308-50
EstradiolEstradiol .5 mg/1TabletOralDirect_Rx72189-65572189-0655-60
EstradiolEstradiol .5 mg/1TabletOralCoupler LLC67046-156867046-1568-03
EstradiolEstradiol 1 mg/1TabletOralAmerican Health Packaging60687-87660687-0876-65
EstradiolEstradiol 1 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-886068788-8860-0168788-8860-0368788-8860-06+1 more
EstradiolEstradiol .75 mg/1.25gGel, MeteredTopicalANI Pharmaceuticals, Inc.70954-64670954-0646-10
Estradiolestradiol transdermalEstradiol 1.25 mg/1.25gGelTopicalAmneal Pharmaceuticals NY LLC69238-244869238-2448-03
Estradiolestradiol transdermalEstradiol 1 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-244969238-2449-03
Estradiolestradiol transdermalEstradiol .75 mg/.75gGelTopicalAmneal Pharmaceuticals NY LLC69238-245069238-2450-03

All 182 Estradiol NDCs

Other NDCs under ANDA 086069

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

FDA NDC Directory listings under ANDA 086069
ProductStrengthForm · routeLabelerProduct NDC
EstraceestradiolEstradiol .1 mg/gCreamVaginalA-S Medication Solutions50090-2321
EstraceestradiolEstradiol .1 mg/gCreamVaginalAllergan, Inc.0430-3754
EstradiolEstradiol .1 mg/gCreamVaginalTeva Pharmaceuticals USA, Inc.0093-3541

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