Prescription drug · ANDA

Estradiol NDC 0378-3350

Estradiol .05 mg/d · Patch · Transdermal · Mylan Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0378-3350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-3350Add 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
0378-3350-9900378335099003783350994 POUCH in 1 CARTON (0378-3350-99) / 1 PATCH in 1 POUCH (0378-3350-16) / 7 d in 1 PATCHMarketed from Mar 1, 2000

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)
Estradiol
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .05 mg/d
Dosage form
Patch
Route
Transdermal
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075182
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 0378-3350_49f22eba-c5a4-4264-b905-6a8ff7e0d884SPL ID 49f22eba-c5a4-4264-b905-6a8ff7e0d884SPL set ID e7e6da3b-8485-1382-61c9-e9b369018b98RxCUI 238003, 238004, 241527, 242333, 403922, 403923UNII 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378335099 followed by a unit qualifier and the quantity

Package 00378-3350-99. 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)

Estradiol transdermal system continuous delivery (once-weekly) is indicated for: Estradiol transdermal system continuous delivery (once-weekly) is an estrogen indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Prevention of Postmenopausal Osteoporosis ( 1.4 ) Limitati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-3350

What is NDC 0378-3350?
0378-3350 is the product NDC for Estradiol, Estradiol .05 mg/d patch, listed with the FDA by Mylan Pharmaceuticals 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?
Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?
182 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 183 Estradiol NDCs

Other NDCs under ANDA 075182

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

FDA NDC Directory listings under ANDA 075182
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .025 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-3349
EstradiolEstradiol .075 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-3351
EstradiolEstradiol .1 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-3352
EstradiolEstradiol .0375 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-3360
EstradiolEstradiol .06 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-3361
EstradiolEstradiol .05 mg/dPatchTransdermalA-S Medication Solutions50090-7611
EstradiolEstradiol .1 mg/dPatchTransdermalA-S Medication Solutions50090-7984
EstradiolEstradiol .025 mg/dPatchTransdermalA-S Medication Solutions50090-7985
EstradiolEstradiol .075 mg/dPatchTransdermalA-S Medication Solutions50090-7986
EstradiolEstradiol .0375 mg/dPatchTransdermalA-S Medication Solutions50090-7987
EstradiolEstradiol .06 mg/dPatchTransdermalA-S Medication Solutions50090-7988

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