Pregabalin NDC 69097-961

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-961Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0961Add 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
69097-961-05	69097096105	90 CAPSULE in 1 BOTTLE (69097-961-05)Marketed from Jul 19, 2019

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): Pregabalin
Generic name (nonproprietary): pregabalin
Active ingredients: Pregabalin — 225 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Cipla USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211384
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 69097-961_96d9d734-42e6-474d-a75e-0381de0a8ec1SPL ID 96d9d734-42e6-474d-a75e-0381de0a8ec1SPL set ID 17a8087c-579f-42de-ae92-006ea64def2aRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0369097955052, 0369097957056, 0369097956059, 0369097958053, 0369097954055, 0369097962050, 0369097961053

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

N469097096105 followed by a unit qualifier and the quantity

Package 69097-0961-05. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 211384

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

FDA NDC Directory listings under ANDA 211384
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-765
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-569
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-568
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-572
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-570
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-571
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-573
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-574
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Exelan Pharmaceuticals Inc.	76282-575
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Cipla USA, Inc.	69097-956
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Cipla USA, Inc.	69097-954
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Cipla USA, Inc.	69097-955
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-313
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Cipla USA, Inc.	69097-957
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Cipla USA, Inc.	69097-958
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Cipla USA, Inc.	69097-959
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-318
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Cipla USA, Inc.	69097-962
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-314
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-316

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