Absorica LD (isotretinoin) NDC 10631-007

NDC codes

FDA NDC Directory

Product NDC (as listed)10631-007Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10631-0007Add 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 NDC	11-digit (billing)	Package	Copy
10631-007-31	10631000731	3 BLISTER PACK in 1 BOX (10631-007-31) / 10 CAPSULE in 1 BLISTER PACKMarketed from Nov 20, 2019

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): Absorica LD
Generic name (nonproprietary): isotretinoin
Active ingredients: Isotretinoin — 32 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211913
Marketing start: Nov 20, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 10631-007_a83b6e70-c01f-47c2-8aa3-e8c4148bafa6SPL ID a83b6e70-c01f-47c2-8aa3-e8c4148bafa6SPL set ID 3ef0cff8-19c1-4441-b780-fca6c7ee1615RxCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 1547563, 1547565, 1547567, 2262711, 2262713, 2262714, 2262715, 2262717, 2262719, 2262721, 2262723, 2262725, 2262727, 2262729, 2262731UNII 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

N410631000731 followed by a unit qualifier and the quantity

Package 10631-0007-31. 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 Aug 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

ABSORICA and ABSORICA LD are 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, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 211913

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 211913
Product	Strength	Form · route	Labeler	Product NDC
Absorica LDisotretinoin	Isotretinoin 8 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-002
Absorica LDisotretinoin	Isotretinoin 16 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-003
Absorica LDisotretinoin	Isotretinoin 24 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-005