What is NDC 46708-438?

46708-438 is the product NDC for hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for hydrochlorothiazide?

166 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

hydrochlorothiazide NDC 46708-438 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0438Add 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
46708-438-10	4670804381046708043810	10 BLISTER PACK in 1 CARTON (46708-438-10) / 10 CAPSULE in 1 BLISTER PACKMarketed from Mar 2, 2017
46708-438-30	4670804383046708043830	30 CAPSULE in 1 BOTTLE (46708-438-30)Marketed from Mar 2, 2017
46708-438-31	4670804383146708043831	100 CAPSULE in 1 BOTTLE (46708-438-31)Marketed from Mar 2, 2017
46708-438-71	4670804387146708043871	500 CAPSULE in 1 BOTTLE (46708-438-71)Marketed from Mar 2, 2017
46708-438-91	4670804389146708043891	1000 CAPSULE in 1 BOTTLE (46708-438-91)Marketed from Mar 2, 2017

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): hydrochlorothiazide
Generic name (nonproprietary): hydrochlorothiazide
Active ingredients: Hydrochlorothiazide — 12.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200645
Marketing start: Mar 2, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 46708-438_8ed60738-80b1-4c2d-a0f1-cf5fa17f8308SPL ID 8ed60738-80b1-4c2d-a0f1-cf5fa17f8308SPL set ID 34703033-14c4-459c-8b8f-2f2e1145aff7RxCUI 199903UNII 0J48LPH2THUPC 0346708438302
Pharmacologic class: 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

N446708043810 followed by a unit qualifier and the quantity

Package 46708-0438-10. 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 Jan 30, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrochlorothiazide capsules, USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxem…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-438

What is NDC 46708-438?: 46708-438 is the product NDC for hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: hydrochlorothiazide.
What is the active ingredient?: Hydrochlorothiazide.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for hydrochlorothiazide?: 166 other product NDCs are listed under this name. See all 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 hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/5mL	SolutionOral	Advagen Pharma Ltd	72888-491	72888-0491-01
Hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	TabletOral	Teva Pharmaceuticals, Inc.	0480-3444	00480-3444-10
hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4192	68788-4192-0168788-4192-0368788-4192-06+2 more
Hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4736	70518-4736-00
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-038	87441-0038-01
Hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	TabletOral	Coupler LLC	67046-1664	67046-1664-03
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	American Health Packaging	60687-894	60687-0894-01
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4525	70518-4525-00
Hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4466	70518-4466-0070518-4466-01
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4359	70518-4359-0070518-4359-0170518-4359-02+2 more

All 167 hydrochlorothiazide NDCs

Other NDCs under ANDA 200645

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

FDA NDC Directory listings under ANDA 200645
Product	Strength	Form · route	Labeler	Product NDC
hydrochlorothiazide	Hydrochlorothiazide 12.5 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-070