NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2829Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2829Add 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
70518-2829-070518282900100 POUCH in 1 BOX (70518-2829-0) / 1 TABLET in 1 POUCH (70518-2829-1)Marketed from Aug 7, 2020

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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
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 70518-2829_4ab6abd7-1b7a-0729-e063-6394a90aa74fSPL ID 4ab6abd7-1b7a-0729-e063-6394a90aa74fSPL set ID 170ec388-d399-4543-8743-208394b38904RxCUI 197659UNII 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

N470518282900 followed by a unit qualifier and the quantity

Package 70518-2829-00. 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 tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis. W…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-2829

What is NDC 70518-2829?
70518-2829 is the product NDC for Estradiol, Estradiol 2 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 1 mg/1TabletOralREMEDYREPACK INC.70518-3818
EstradiolEstradiol .5 mg/1TabletOralBryant Ranch Prepack71335-0226
EstradiolEstradiol 1 mg/1TabletOralBryant Ranch Prepack71335-0797
EstradiolEstradiol 1 mg/1TabletOralDirect_Rx72189-502
EstradiolEstradiol 2 mg/1TabletOralDirect_Rx72189-508

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