Prescription drug · ANDA
Estradiol NDC 0378-3361
Estradiol .06 mg/d · Patch · Transdermal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3361-99 | 00378336199 | 4 POUCH in 1 CARTON (0378-3361-99) / 1 PATCH in 1 POUCH (0378-3361-16) / 7 d in 1 PATCHMarketed from Aug 9, 2006 |
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 — .06 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Mylan Pharmaceuticals Inc.
- 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 0378-3361_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
N400378336199followed by a unit qualifier and the quantityPackage 00378-3361-99. 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.
Other NDCs under ANDA 075182
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estradiol | Estradiol .1 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3352 |
| Estradiol | Estradiol .025 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3349 |
| Estradiol | Estradiol .05 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3350 |
| Estradiol | Estradiol .075 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3351 |
| Estradiol | Estradiol .0375 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-3360 |
| Estradiol | Estradiol .025 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7985 |
| Estradiol | Estradiol .1 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7984 |
| Estradiol | Estradiol .075 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7986 |
| Estradiol | Estradiol .0375 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7987 |
| Estradiol | Estradiol .06 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7988 |
| Estradiol | Estradiol .05 mg/d | PatchTransdermal | A-S Medication Solutions | 50090-7611 |