NDC codes

FDA NDC Directory
Product NDC (as listed)0093-1138Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-1138Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0093-1138-560009311385630 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

N400093113856 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acitretin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AcitretinAcitretin 10 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-74146708-0741-30
AcitretinAcitretin 17.5 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-74246708-0742-30
AcitretinAcitretin 25 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-74346708-0743-30
AcitretinAcitretin 10 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-74162332-0741-30
AcitretinAcitretin 17.5 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-74262332-0742-30
AcitretinAcitretin 25 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-74362332-0743-30
AcitretinAcitretin 10 mg/1CapsuleOralAvKARE42291-08642291-0086-30
AcitretinAcitretin 17.5 mg/1CapsuleOralAvKARE42291-08742291-0087-30
AcitretinAcitretin 25 mg/1CapsuleOralAvKARE42291-08842291-0088-30
AcitretinAcitretin 10 mg/1CapsuleOralMylan Pharmaceuticals Inc.0378-702000378-7020-93

All 22 Acitretin NDCs

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