What is NDC 70771-1558?

70771-1558 is the product NDC for Isotretinoin, Isotretinoin 20 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Isotretinoin?

66 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isotretinoin NDC 70771-1558 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1558Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1558Add 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
70771-1558-4	7077115580470771155804	10 BLISTER PACK in 1 CARTON (70771-1558-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 12, 2023
70771-1558-8	7077115580870771155808	3 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 12, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Isotretinoin
Generic name (nonproprietary): isotretinoin
Active ingredients: Isotretinoin — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211568
Marketing start: Sep 12, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 70771-1558_b071eb5c-28f7-4b86-b4e9-7c98da2f19dfSPL ID b071eb5c-28f7-4b86-b4e9-7c98da2f19dfSPL set ID dae33df0-386c-4db5-9759-7096e770ed17RxCUI 197843, 197844, 197845, 403930UNII 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

N470771155804 followed by a unit qualifier and the quantity

Package 70771-1558-04. 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 Nov 30, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1558

What is NDC 70771-1558?: 70771-1558 is the product NDC for Isotretinoin, Isotretinoin 20 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Isotretinoin.
What is the active ingredient?: Isotretinoin.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isotretinoin?: 66 other product NDCs are listed under this name. See all Isotretinoin 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 Isotretinoin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-009	84386-0009-03
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-010	84386-0010-03
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-011	84386-0011-03
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1254	69238-1254-03
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1255	69238-1255-03
Isotretinoin	Isotretinoin 25 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1256	69238-1256-03
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1257	69238-1257-03
Isotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1258	69238-1258-03
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1259	69238-1259-03
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1574	70710-1574-08

All 67 Isotretinoin NDCs

Other NDCs under ANDA 211568

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

FDA NDC Directory listings under ANDA 211568
Product	Strength	Form · route	Labeler	Product NDC
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1022
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1023
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1024
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1025
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1557
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1559
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1560