What is NDC 69097-789?

69097-789 is the product NDC for Pravastatin Sodium, Pravastatin sodium 20 mg/1 tablet, listed with the FDA by CIPLA USA INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

CIPLA USA INC., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pravastatin Sodium?

184 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pravastatin Sodium NDC 69097-789 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-789Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0789Add 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
69097-789-05	6909707890569097078905	90 TABLET in 1 BOTTLE (69097-789-05)Marketed from Jun 1, 2024
69097-789-12	6909707891269097078912	500 TABLET in 1 BOTTLE (69097-789-12)Marketed from Jun 1, 2024

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): Pravastatin Sodium
Generic name (nonproprietary): pravastatin sodium
Active ingredients: Pravastatin sodium — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: CIPLA USA INC.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077987
Marketing start: Jun 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 69097-789_61857346-86ef-4414-875f-7c205dacf301SPL ID 61857346-86ef-4414-875f-7c205dacf301
Pharmacologic class: HMG-CoA Reductase 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

N469097078905 followed by a unit qualifier and the quantity

Package 69097-0789-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69097-789

What is NDC 69097-789?: 69097-789 is the product NDC for Pravastatin Sodium, Pravastatin sodium 20 mg/1 tablet, listed with the FDA by CIPLA USA INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pravastatin Sodium.
What is the active ingredient?: Pravastatin sodium.
Who is the labeler?: CIPLA USA INC., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pravastatin Sodium?: 184 other product NDCs are listed under this name. See all Pravastatin Sodium 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 Pravastatin Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pravastatin Sodium	Pravastatin sodium 30 mg/1	TabletOral	Havix Group Inc d-b-a Aavis Pharmaceuticals	71337-289	71337-0289-09
Pravastatin Sodium	Pravastatin sodium 60 mg/1	TabletOral	Havix Group Inc d-b-a Aavis Pharmaceuticals	71337-290	71337-0290-09
Pravastatin sodium	Pravastatin sodium 80 mg/1	TabletOral	Aurobindo Pharma Limited	84386-167	84386-0167-9084386-0167-99
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	Amici Pharma, Inc.	69292-101	69292-0101-1069292-0101-5069292-0101-90
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	Amici Pharma, Inc.	69292-102	69292-0102-1069292-0102-5069292-0102-90
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	Amici Pharma, Inc.	69292-103	69292-0103-1069292-0103-5069292-0103-90
Pravastatin Sodium	Pravastatin sodium 80 mg/1	TabletOral	Amici Pharma, Inc.	69292-104	69292-0104-1069292-0104-5069292-0104-90
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	Northwind Health Company, LLC	82868-104	82868-0104-30
Pravastatin sodium	Pravastatin sodium 20 mg/1	TabletOral	Safecor Health LLC	48433-148	48433-0148-20
Pravastatin sodium	Pravastatin sodium 40 mg/1	TabletOral	Safecor Health LLC	48433-149	48433-0149-20

All 185 Pravastatin Sodium NDCs

Other NDCs under ANDA 077987

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

FDA NDC Directory listings under ANDA 077987
Product	Strength	Form · route	Labeler	Product NDC
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	A-S Medication Solutions	50090-1533
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	A-S Medication Solutions	50090-1594
Pravastatin Sodium	Pravastatin sodium 80 mg/1	TabletOral	A-S Medication Solutions	50090-5809
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8421
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8425
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	A-S Medication Solutions	50090-7709
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	A-S Medication Solutions	50090-0975
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	A-S Medication Solutions	50090-7710
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	American Health Packaging	60687-886
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	CIPLA USA INC.	69097-788
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	CIPLA USA INC.	69097-791
Pravastatin Sodium	Pravastatin sodium 80 mg/1	TabletOral	CIPLA USA INC.	69097-792
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8540
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	American Health Packaging	60687-897
Pravastatin Sodium	Pravastatin sodium 10 mg/1	TabletOral	Coupler LLC	67046-1518
Pravastatin Sodium	Pravastatin sodium 20 mg/1	TabletOral	Coupler LLC	67046-1519
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	American Health Packaging	60687-908
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8541
Pravastatin Sodium	Pravastatin sodium 80 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8542
Pravastatin Sodium	Pravastatin sodium 40 mg/1	TabletOral	Northwind Health Company, LLC	51655-594

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