What is NDC 0378-2085?

0378-2085 is the product NDC for Dexlansoprazole, Dexlansoprazole sesquihydrate 30 mg/1 capsule, delayed release pellets, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dexlansoprazole?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexlansoprazole NDC 0378-2085 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2085Add 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
0378-2085-93	0037820859300378208593	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)Marketed from Jan 22, 2024

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): Dexlansoprazole
Generic name (nonproprietary): dexlansoprazole
Active ingredients: Dexlansoprazole sesquihydrate — 30 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205205
Marketing start: Jan 22, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0aSPL ID bd08545b-3f1d-44c5-bdd9-05acd7f69a0aSPL set ID 3f9699b5-7614-41cb-bd1d-ff02930e98f3RxCUI 833204, 833213UNII HS2S9VK3NHUPC 0303782086935, 0303782085938
Pharmacologic class: Proton Pump Inhibitor

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

N400378208593 followed by a unit qualifier and the quantity

Package 00378-2085-93. 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 Jul 15, 2023.

Indications (excerpt from the label)

Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: • Healing of all grades of erosive esophagitis (EE). ( 1.1 ) • Maintenance of healed EE and relief of heartburn. ( 1.2 ) • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and ol…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-2085

What is NDC 0378-2085?: 0378-2085 is the product NDC for Dexlansoprazole, Dexlansoprazole sesquihydrate 30 mg/1 capsule, delayed release pellets, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexlansoprazole.
What is the active ingredient?: Dexlansoprazole sesquihydrate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexlansoprazole?: 10 other product NDCs are listed under this name. See all Dexlansoprazole 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 Dexlansoprazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexlansoprazole	Dexlansoprazole 30 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-823	46708-0823-3046708-0823-90
Dexlansoprazole	Dexlansoprazole 60 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-824	46708-0824-3046708-0824-90
Dexlansoprazole	Dexlansoprazole 30 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-823	62332-0823-3062332-0823-90
Dexlansoprazole	Dexlansoprazole 60 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-824	62332-0824-3062332-0824-90
Dexlansoprazole	Dexlansoprazole sesquihydrate 60 mg/1	Capsule, Delayed release pelletsOral	Mylan Pharmaceuticals Inc.	0378-2086	00378-2086-7700378-2086-93
Dexlansoprazole	Dexlansoprazole 30 mg/1	Capsule, Delayed releaseOral	Par Health USA, LLC	49884-147	49884-0147-11
Dexlansoprazole	Dexlansoprazole 30 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	72162-2244	72162-2244-03
Dexlansoprazole	Dexlansoprazole 60 mg/1	Capsule, Delayed releaseOral	Par Health USA, LLC	49884-148	49884-0148-0949884-0148-11
Dexlansoprazole	Dexlansoprazole 60 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7451	50090-7451-0050090-7451-01
Dexlansoprazole	Dexlansoprazole 60 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	72162-2214	72162-2214-03

Other NDCs under ANDA 205205

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

FDA NDC Directory listings under ANDA 205205
Product	Strength	Form · route	Labeler	Product NDC
Dexlansoprazole	Dexlansoprazole sesquihydrate 60 mg/1	Capsule, Delayed release pelletsOral	Mylan Pharmaceuticals Inc.	0378-2086