What is NDC 0378-2921?

0378-2921 is the product NDC for Telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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 Telmisartan?

79 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Telmisartan NDC 0378-2921 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2921Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2921Add 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
0378-2921-77	0037829217700378292177	90 TABLET in 1 BOTTLE, PLASTIC (0378-2921-77)Marketed from Jul 7, 2014
0378-2921-93	0037829219300378292193	30 TABLET in 1 BOTTLE, PLASTIC (0378-2921-93)Marketed from Jul 7, 2014

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): Telmisartan
Generic name (nonproprietary): telmisartan
Active ingredients: Telmisartan — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202397
Marketing start: Jul 7, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-2921_0bdc0a35-e9b0-41a9-96f8-5b85497298f9SPL ID 0bdc0a35-e9b0-41a9-96f8-5b85497298f9SPL set ID c3658bc8-1524-43db-930e-66f9ac01b808RxCUI 205304, 205305, 282755UNII U5SYW473RQUPC 0303782921939, 0303782920932, 0303782922936
Pharmacologic class: Angiotensin 2 Receptor Blocker

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

N400378292177 followed by a unit qualifier and the quantity

Package 00378-2921-77. 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 Mar 15, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-2921

What is NDC 0378-2921?: 0378-2921 is the product NDC for Telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Telmisartan.
What is the active ingredient?: Telmisartan.
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 Telmisartan?: 79 other product NDCs are listed under this name. See all Telmisartan 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 Telmisartan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Telmisartan	Telmisartan 20 mg/1	TabletOral	Redpharm Drug	67296-2284	67296-2284-09
Telmisartan	Telmisartan 40 mg/1	TabletOral	NorthStar RxLLC	72603-832	72603-0832-01
Telmisartan	Telmisartan 20 mg/1	TabletOral	NorthStar RxLLC	72603-831	72603-0831-01
Telmisartan	Telmisartan 80 mg/1	TabletOral	NorthStar RxLLC	72603-833	72603-0833-01
Telmisartan	Telmisartan 40 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4034	68788-4034-03
Telmisartan	Telmisartan 20 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-118	33342-0118-0733342-0118-10
Telmisartan	Telmisartan 40 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-119	33342-0119-0733342-0119-10
Telmisartan	Telmisartan 80 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-120	33342-0120-0733342-0120-10
Telmisartan	Telmisartan 80 mg/1	TabletOral	Lifestar Pharma LLC	70756-314	70756-0314-3070756-0314-80
Telmisartan	Telmisartan 20 mg/1	TabletOral	Lifestar Pharma LLC	70756-312	70756-0312-3070756-0312-99

All 80 Telmisartan NDCs

Other NDCs under ANDA 202397

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

FDA NDC Directory listings under ANDA 202397
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan	Telmisartan 20 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-2920
Telmisartan	Telmisartan 80 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-2922
Telmisartan	Telmisartan 40 mg/1	TabletOral	A-S Medication Solutions	50090-5490
Telmisartan	Telmisartan 80 mg/1	TabletOral	A-S Medication Solutions	50090-5492