Prescription drug · ANDA
Tydemy NDC 68180-904
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-904-73 | 68180090473 | 3 POUCH in 1 CARTON (68180-904-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-905-74) * 7 TABLET, FILM COATED in 1 BLISTER PACK (68180-910-74)Marketed from Nov 20, 2020 |
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)
- Tydemy
- 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 205948
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-904_9229c82f-e84e-4805-90d2-a77e0fad63b5SPL ID 9229c82f-e84e-4805-90d2-a77e0fad63b5SPL set ID e4766132-4faa-4f76-89fe-75d4a6fd737bRxCUI 1013628, 1050492, 1050493, 1999724UPC 0368180904717
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
N468180090473followed by a unit qualifier and the quantityPackage 68180-0904-73. 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)
Tydemy 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 ) Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) 1.1 Oral Contraceptive Tydemy TM is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Folate Supplementation Tydemy is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived w…
Excerpt only. Read the full label for complete information.
About NDC 68180-904
- What is NDC 68180-904?
- 68180-904 is the product NDC for Tydemy 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?
- Tydemy (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 Tydemy?
- 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.