Prescription drug · ANDA
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium NDC 68180-894
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-894-73 | 68180089473 | 3 POUCH in 1 CARTON (68180-894-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Aug 22, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium
- Generic name (nonproprietary)
- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205947
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-894_f5347764-c224-4ba9-b57a-90a228f1ee07SPL ID f5347764-c224-4ba9-b57a-90a228f1ee07SPL set ID 48f4301c-0426-43cd-af37-c4d8fc7aeb67RxCUI 1013626, 1013628, 1013629UPC 0368180894711
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
N468180089473followed by a unit qualifier and the quantityPackage 68180-0894-73. 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)
Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) Raise folate levels in females of reproductive potential who choose to use an oral contraceptive …
Excerpt only. Read the full label for complete information.
About NDC 68180-894
- What is NDC 68180-894?
- 68180-894 is the product NDC for drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.