Prescription drug · ANDA
Acitretin NDC 0093-1138
Acitretin 17.5 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-1138-56 | 00093113856 | 30 CAPSULE in 1 BOTTLE (0093-1138-56)Marketed from Jul 19, 2013 |
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)
- Acitretin
- Generic name (nonproprietary)
- acitretin
- Active ingredients
- Acitretin — 17.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202897
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0093-1138_11579624-a4a1-4db1-bf72-9fbedbce3225SPL ID 11579624-a4a1-4db1-bf72-9fbedbce3225SPL set ID 993a5325-cd10-4450-b5ea-1c0a90510df6RxCUI 199689, 199690, 894859UNII LCH760E9T7UPC 0300931138569, 0300931135568
- 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
N400093113856followed by a unit qualifier and the quantityPackage 00093-1138-56. 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 Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated…
Excerpt only. Read the full label for complete information.
About NDC 0093-1138
- What is NDC 0093-1138?
- 0093-1138 is the product NDC for Acitretin, Acitretin 17.5 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acitretin.
- What is the active ingredient?
- Acitretin.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acitretin?
- 21 other product NDCs are listed under this name. See all Acitretin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acitretin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-741 | 46708-0741-30 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-742 | 46708-0742-30 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-743 | 46708-0743-30 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-741 | 62332-0741-30 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-742 | 62332-0742-30 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-743 | 62332-0743-30 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | AvKARE | 42291-086 | 42291-0086-30 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | AvKARE | 42291-087 | 42291-0087-30 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | AvKARE | 42291-088 | 42291-0088-30 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-7020 | 00378-7020-93 |