Prescription drug · ANDA
Zenatane (Isotretinoin) NDC 55111-137
Isotretinoin 40 mg/1 · Capsule, Gelatin coated · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-137-81 | 5511101378155111013781 | 3 BLISTER PACK in 1 CARTON (55111-137-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-137-79)Marketed from Mar 26, 2013 |
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)
- Zenatane
- Generic name (nonproprietary)
- isotretinoin
- Active ingredients
- Isotretinoin — 40 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202099
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 55111-137_5ec3c90d-0070-76b9-af16-0f380eb9d497SPL ID 5ec3c90d-0070-76b9-af16-0f380eb9d497
- Pharmacologic class
- Retinoid
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455111013781followed by a unit qualifier and the quantityPackage 55111-0137-81. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 55111-137
- What is NDC 55111-137?
- 55111-137 is the product NDC for Zenatane (isotretinoin), Isotretinoin 40 mg/1 capsule, gelatin coated, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zenatane (Isotretinoin).
- What is the active ingredient?
- Isotretinoin.
- Who is the labeler?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zenatane?
- 7 other product NDCs are listed under this name. See all Zenatane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zenatane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-652 | 68001-0652-17 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-653 | 68001-0653-17 |
| Zenataneisotretinoin | Isotretinoin 40 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-655 | 68001-0655-17 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-654 | 68001-0654-17 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-113 | 55111-0113-7855111-0113-81 |
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-135 | 55111-0135-81 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-136 | 55111-0136-81 |
Other NDCs under ANDA 202099
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 |
|---|---|---|---|---|
| Accutaneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-251 |
| Accutaneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-252 |
| Accutaneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-253 |
| Accutaneisotretinoin | Isotretinoin 40 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-254 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-113 |
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-135 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-136 |
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-652 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-653 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-654 |
| Zenataneisotretinoin | Isotretinoin 40 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-655 |