Prescription drug · ANDA
Norgestimate and ethinyl estradiol NDC 68180-838
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-838-73 | 68180083873 | 3 CARTON in 1 CARTON (68180-838-73) / 1 KIT in 1 CARTONMarketed from Aug 8, 2019 |
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)
- Norgestimate and ethinyl estradiol
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- 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 205588
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-838_75083930-2ca4-48c9-a233-24783a0e50d4SPL ID 75083930-2ca4-48c9-a233-24783a0e50d4SPL set ID 6e8bec6f-17ba-4b37-ae6c-07657815f248RxCUI 240128, 406396, 687424, 748797, 749784UPC 0368180838715
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
N468180083873followed by a unit qualifier and the quantityPackage 68180-0838-73. 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)
Norgestimate and ethinyl estradiol tablets USP are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Norgestimate and ethinyl estradiol tablets USP is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Norgestimate and ethinyl estradiol tablets USP are indicated f…
Excerpt only. Read the full label for complete information.
About NDC 68180-838
- What is NDC 68180-838?
- 68180-838 is the product NDC for Norgestimate and ethinyl estradiol 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?
- Norgestimate and ethinyl estradiol.
- 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 Norgestimate and ethinyl estradiol?
- 13 other product NDCs are listed under this name. See all Norgestimate and ethinyl estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norgestimate and ethinyl estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norgestimate and ethinyl estradiol | — | Kit | Naari Pte Limited | 79929-008 | 79929-0008-07 |
| Norgestimate and ethinyl estradiol | — | Kit | Naari Pte Limited | 79929-009 | 79929-0009-07 |
| Norgestimate and Ethinyl Estradiol | — | Kit | AvKARE | 42291-553 | 42291-0553-84 |
| Norgestimate and Ethinyl Estradiol | — | Kit | AvKARE | 42291-565 | 42291-0565-84 |
| norgestimate and ethinyl estradiol | — | Kit | AvKARE | 42291-590 | 42291-0590-84 |
| norgestimate and ethinyl estradiol | — | Kit | PD-Rx Pharmaceuticals, Inc. | 72789-435 | 72789-0435-79 |
| Norgestimate and Ethinyl Estradiol | — | Kit | Lupin Pharmaceuticals, Inc. | 68180-840 | 68180-0840-73 |
| Norgestimate and Ethinyl Estradiol | — | Kit | A-S Medication Solutions | 50090-2259 | 50090-2259-00 |
| Norgestimate and Ethinyl Estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-309 | 68462-0309-29 |
| Norgestimate and Ethinyl Estradiol | — | Kit | A-S Medication Solutions | 50090-2603 | 50090-2603-00 |