Pregabalin NDC 63629-8197

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8197Add 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
63629-8197-1	63629819701	30 CAPSULE in 1 BOTTLE (63629-8197-1)Marketed from Aug 1, 2019
63629-8197-2	63629819702	90 CAPSULE in 1 BOTTLE (63629-8197-2)Marketed from Jul 25, 2019
63629-8197-3	63629819703	60 CAPSULE in 1 BOTTLE (63629-8197-3)Marketed from Aug 1, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2027
DEA schedule: CV
Identifiers: Product ID 63629-8197_e388e363-0fd6-4103-b87a-a5f018c7d299SPL ID e388e363-0fd6-4103-b87a-a5f018c7d299SPL set ID fd568ede-dac7-4910-bb18-65fb00f2636eRxCUI 483438UNII 55JG375S6M

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

N463629819701 followed by a unit qualifier and the quantity

Package 63629-8197-01. 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 208677

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

FDA NDC Directory listings under ANDA 208677
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-808
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0433
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-304
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0177
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-870
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Proficient Rx LP	71205-869
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Proficient Rx LP	71205-874
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-871
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-872
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-873
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Proficient Rx LP	71205-876
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Proficient Rx LP	71205-323
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Proficient Rx LP	71205-875
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3118
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-799
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-800
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-820
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Proficient Rx LP	71205-396
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Proficient Rx LP	71205-677
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7522

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