Isotretinoin Capsule, Liquid Filled
NDC Package 68308-784-30

11-digit billing NDC: 68308078430 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Isotretinoin capsules is must not be used by patients who are or may become pregnant. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Mayne Pharma, this product is identified by NDC 68308-784 and is authorized under FDA application ANDA076485.

Identification & Billing

NDC Package Code
68308-784-30
Package Description
3 BLISTER PACK in 1 BOX / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-784-01)
Product Code
68308-784
11-Digit Billing Format
68308078430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isotretinoin
Non-Proprietary Name
Isotretinoin
Substance Name
Isotretinoin
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ISOTRETINOIN 40 mg/1
Pharmacologic Class
Usage Information
Isotretinoin capsules must not be used by patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.Birth defects which have been documented following isotretinoin capsules exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.If pregnancy does occur during treatment of a patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.Special Prescribing RequirementsBecause of isotretinoin teratogenicity and to minimize fetal exposure, isotretinoin capsules approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This REMS is called iPLEDGE ®. Isotretinoin capsules must only be prescribed by prescribers who are enrolled and activated with the iPLEDGE REMS. Isotretinoin capsule smust only be dispensed by a pharmacy enrolled and activated with iPLEDGE, and must only be dispensed to patients who are enrolled andmeet all the requirements of iPLEDGE (see PRECAUTIONS).

Regulatory & Marketing

Labeler Name
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA076485
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68308-784-30 identifies a specific commercial package of 3 blister pack in 1 box / 10 capsule, liquid filled in 1 blister pack (68308-784-01) of Isotretinoin, a human prescription drug labeled by Mayne Pharma. This capsule, liquid filled is formulated for oral use and contains isotretinoin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mayne Pharma on May 01, 2012. The current certification is valid through December 31, 2026.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308078430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68308-784-30
11-Digit CMS (5-4-2)
68308-0784-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.