NDC codes

FDA NDC Directory
Product NDC (as listed)43598-298Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0298Add 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 NDC11-digit (billing)PackageCopy
43598-298-054359802980543598029805500 CAPSULE in 1 BOTTLE (43598-298-05)Marketed from Jul 19, 2019
43598-298-6643598029866435980298665 BLISTER PACK in 1 CARTON (43598-298-66) / 10 CAPSULE in 1 BLISTER PACK (43598-298-79)Marketed from Jul 19, 2019
43598-298-78435980298784359802987810 BLISTER PACK in 1 CARTON (43598-298-78) / 10 CAPSULE in 1 BLISTER PACK (43598-298-79)Marketed from Jul 19, 2019
43598-298-90435980298904359802989090 CAPSULE in 1 BOTTLE (43598-298-90)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 — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Dr.Reddys Laboratories IncNDC labeler code 43598
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209664
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 43598-298_4a1e5038-d049-606f-c087-48bc353a8a69SPL ID 4a1e5038-d049-606f-c087-48bc353a8a69SPL set ID ceed457b-8f43-4021-fd70-071c96e09470RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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

N443598029805 followed by a unit qualifier and the quantity

Package 43598-0298-05. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropath y • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 Month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) • Postherpetic neuralgia (PHN) (1) • Adjunctive therapy for for the treatment of partial-onset seizures in patients 1 month of age and older (1) • Fibromyalgia (1) • Neuropathic pain associated with spinal cord injury (1)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-298

What is NDC 43598-298?
43598-298 is the product NDC for pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Dr.Reddys Laboratories Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
pregabalin.
What is the active ingredient?
Pregabalin.
Who is the labeler?
Dr.Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pregabalin?
503 other product NDCs are listed under this name. See all pregabalin 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 pregabalin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PregabalinPregabalin 200 mg/1CapsuleOralREMEDYREPACK INC.70518-474970518-4749-00
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-474370518-4743-00
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19
PregabalinPregabalin 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44329300-0443-19
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44429300-0444-19
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19

All 504 pregabalin NDCs

Other NDCs under ANDA 209664

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

FDA NDC Directory listings under ANDA 209664
ProductStrengthForm · routeLabelerProduct NDC
pregabalinPregabalin 25 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-291
pregabalinPregabalin 50 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-292
pregabalinPregabalin 75 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-293
pregabalinPregabalin 100 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-294
pregabalinPregabalin 150 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-295
pregabalinPregabalin 200 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-296
pregabalinPregabalin 225 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-297

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