Prescription drug · ANDA
Amnesteem (Isotretinoin) NDC 0378-6614
Isotretinoin 40 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6614-93 | 0037866149300378661493 | 3 BLISTER PACK in 1 CARTON (0378-6614-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)Marketed from Nov 11, 2002 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Amnesteem
- Generic name (nonproprietary)
- isotretinoin
- Active ingredients
- Isotretinoin — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075945
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0378-6614_4e5dc880-a474-43c1-b126-9cce9e6d066fSPL ID 4e5dc880-a474-43c1-b126-9cce9e6d066fSPL set ID b2cb63c9-f825-4991-9a2c-6260f1bbcc2cRxCUI 197843, 197844, 197845, 403930, 404058, 404061, 404064, 2711694UNII EH28UP18IF
- 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
N400378661493followed by a unit qualifier and the quantityPackage 00378-6614-93. 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)
Amnesteem is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Amnesteem is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of Amnesteem treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2) ]. Amnesteem is a retinoid indica…
Excerpt only. Read the full label for complete information.
About NDC 0378-6614
- What is NDC 0378-6614?
- 0378-6614 is the product NDC for Amnesteem (isotretinoin), Isotretinoin 40 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amnesteem (Isotretinoin).
- What is the active ingredient?
- Isotretinoin.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amnesteem?
- 3 other product NDCs are listed under this name. See all Amnesteem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amnesteem products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amnesteemisotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6613 | 00378-6613-93 |
| Amnesteemisotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6611 | 00378-6611-93 |
| Amnesteemisotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6612 | 00378-6612-93 |
Other NDCs under ANDA 075945
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 |
|---|---|---|---|---|
| Amnesteemisotretinoin | Isotretinoin 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6611 |
| Amnesteemisotretinoin | Isotretinoin 20 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6612 |
| Amnesteemisotretinoin | Isotretinoin 30 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6613 |