NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0226Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0226Add 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
71335-0226-17133502260130 TABLET in 1 BOTTLE (71335-0226-1)Marketed from Jun 29, 2018
71335-0226-271335022602100 TABLET in 1 BOTTLE (71335-0226-2)Marketed from Dec 27, 2021
71335-0226-37133502260390 TABLET in 1 BOTTLE (71335-0226-3)Marketed from May 7, 2018
71335-0226-47133502260460 TABLET in 1 BOTTLE (71335-0226-4)Marketed from Dec 27, 2021

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 — .5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040275
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 71335-0226_4593e1f2-65b0-4a0f-ac69-0f2be718c63eSPL ID 4593e1f2-65b0-4a0f-ac69-0f2be718c63eSPL set ID fad3813c-9495-416b-9789-623d5758b4e3RxCUI 197657UNII 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 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

N471335022601 followed by a unit qualifier and the quantity

Package 71335-0226-01. 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 tablets are indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. Prevention …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0226

What is NDC 71335-0226?
71335-0226 is the product NDC for Estradiol, Estradiol .5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 040275

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

FDA NDC Directory listings under ANDA 040275
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .5 mg/1TabletOralPURACAP LABORATORIES, LLC24658-702
EstradiolEstradiol 1 mg/1TabletOralPURACAP LABORATORIES, LLC24658-703
EstradiolEstradiol 2 mg/1TabletOralPURACAP LABORATORIES, LLC24658-704
EstradiolEstradiol .5 mg/1TabletOralEPIC PHARMA, LLC42806-087
EstradiolEstradiol 1 mg/1TabletOralEPIC PHARMA, LLC42806-088
EstradiolEstradiol 2 mg/1TabletOralEPIC PHARMA, LLC42806-089
EstradiolEstradiol .5 mg/1TabletOralA-S Medication Solutions50090-5494
EstradiolEstradiol 1 mg/1TabletOralA-S Medication Solutions50090-6359
EstradiolEstradiol 2 mg/1TabletOralA-S Medication Solutions50090-6363
EstradiolEstradiol 1 mg/1TabletOralA-S Medication Solutions50090-7452
EstradiolEstradiol .5 mg/1TabletOralNorthwind Health Company, LLC51655-860
EstradiolEstradiol 2 mg/1TabletOralBryant Ranch Prepack63629-4788
EstradiolEstradiol 1 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3394
EstradiolEstradiol 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4485
EstradiolEstradiol 1 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7102
EstradiolEstradiol 2 mg/1TabletOralREMEDYREPACK INC.70518-2829
EstradiolEstradiol 1 mg/1TabletOralREMEDYREPACK INC.70518-3818
EstradiolEstradiol 1 mg/1TabletOralBryant Ranch Prepack71335-0797
EstradiolEstradiol 1 mg/1TabletOralDirect_Rx72189-502
EstradiolEstradiol 2 mg/1TabletOralDirect_Rx72189-508

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