Prescription drug · ANDA
Tilia Fe NDC 75907-086
ndac and ee tablets and ferrous fumarate tablets · Kit · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-086-28 | 75907008628 | 1 BLISTER PACK in 1 PACKET (75907-086-28) / 1 KIT in 1 BLISTER PACKMarketed from Jun 1, 2024 | |
| 75907-086-32 | 75907008632 | 3 BLISTER PACK in 1 CARTON (75907-086-32) / 1 KIT in 1 BLISTER PACKMarketed from Jun 1, 2024 |
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)
- Tilia Fe
- Generic name (nonproprietary)
- ndac and ee tablets and ferrous fumarate tablets
- Dosage form
- Kit
- Labeler
- Dr. Reddys Laboratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202962
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-086_af37ed43-957f-4f93-935c-6c2158ab0e15SPL ID af37ed43-957f-4f93-935c-6c2158ab0e15SPL set ID 118fb017-b44d-4223-ac5a-501ca96de210RxCUI 259176, 1358762, 1359130, 1359131, 1359132, 1359134
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
N475907008628followed by a unit qualifier and the quantityPackage 75907-0086-28. 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)
INDICATIONS AND USAGE Tilia Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 list…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202962
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 |
|---|---|---|---|---|
| Tilia Fendac and ee tablets and ferrous fumarate tablets | — | Kit | Mayne Pharma Inc. | 51862-896 |