What is NDC 29300-216?

29300-216 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Irbesartan, Hydrochlorothiazide.

Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Irbesartan and Hydrochlorothiazide?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Irbesartan and Hydrochlorothiazide NDC 29300-216

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0216Add 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
29300-216-10	2930002161029300021610	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10)Marketed from Mar 31, 2018
29300-216-13	2930002161329300021613	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13)Marketed from Mar 31, 2018
29300-216-19	2930002161929300021619	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19)Marketed from Mar 31, 2018

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): Irbesartan and Hydrochlorothiazide
Generic name (nonproprietary): irbesartan and hydrochlorothiazide
Active ingredients: Irbesartan — 300 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207018
Marketing start: Sep 19, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 29300-216_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29aSPL ID a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29aSPL set ID 181324c5-256f-4570-a0bb-8bc908deb2e2RxCUI 310792, 310793UNII 0J48LPH2TH, J0E2756Z7N
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N429300021610 followed by a unit qualifier and the quantity

Package 29300-0216-10. 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 Dec 18, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: In patients not adequately controlled with monotherapy. ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. ( 1 ) Irbesartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets, USP may also be used as initial therapy in patients who are like…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 29300-216

What is NDC 29300-216?: 29300-216 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Irbesartan and Hydrochlorothiazide.
What is the active ingredient?: Irbesartan, Hydrochlorothiazide.
Who is the labeler?: Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Irbesartan and Hydrochlorothiazide?: 28 other product NDCs are listed under this name. See all Irbesartan and Hydrochlorothiazide 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 Irbesartan and Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-1550	70518-1550-0070518-1550-01
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-215	29300-0215-1029300-0215-1329300-0215-19
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-442	46708-0442-1046708-0442-3046708-0442-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-443	46708-0443-1046708-0443-3046708-0443-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-444	46708-0444-1046708-0444-3046708-0444-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-053	62332-0053-1062332-0053-3062332-0053-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-051	62332-0051-1062332-0051-3062332-0051-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-052	62332-0052-1062332-0052-3062332-0052-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-631	65862-0631-0565862-0631-3065862-0631-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2317	72162-2317-0372162-2317-09

All 29 Irbesartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 207018

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

FDA NDC Directory listings under ANDA 207018
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-215