NDC 46708-119

Pregabalin

Pregabalin

Pregabalin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Pregabalin.

• Product ID: 46708-119_78a36538-701d-4dd9-a7fc-87d505784c83
• NDC: 46708-119
• Product Type: Human Prescription Drug
• Proprietary Name: Pregabalin
• Generic Name: Pregabalin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203459
• Labeler Name: Alembic Pharmaceuticals Limited
• Substance Name: PREGABALIN
• Active Ingredient Strength: 25 mg/1
• DEA Schedule: CV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 46708-119-10

100 CAPSULE in 1 CARTON (46708-119-10)

• Marketing Start Date: 2019-07-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-119-90 [46708011990]

Pregabalin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203459
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-19

NDC 46708-119-30 [46708011930]

Pregabalin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203459
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-19

NDC 46708-119-91 [46708011991]

Pregabalin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203459
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-19

NDC 46708-119-10 [46708011910]

Pregabalin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203459
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-19

Drug Details

Active Ingredients

Ingredient	Strength
PREGABALIN	25 mg/1

OpenFDA Data

• SPL SET ID: 78a36538-701d-4dd9-a7fc-87d505784c83
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • 55JG375S6M
• RxNorm Concept Unique ID - RxCUI:
  • 577127
  • 483438
  • 483448
  • 483442
  • 483440
  • 483450
  • 483446
  • 483444
• UPC Code:
  • 0346708122300
  • 0346708126308
  • 0346708125301

NDC Crossover Matching brand name "Pregabalin" or generic name "Pregabalin"

NDC	Brand Name	Generic Name
61919-503	PREGABALIN	PREGABALIN
67877-457	Pregabalin	Pregabalin
67877-469	Pregabalin	Pregabalin
67877-468	Pregabalin	Pregabalin
67877-466	Pregabalin	Pregabalin
67877-465	Pregabalin	Pregabalin
67877-464	Pregabalin	Pregabalin
67877-467	Pregabalin	Pregabalin
69097-962	Pregabalin	Pregabalin
69097-959	Pregabalin	Pregabalin
69097-958	Pregabalin	Pregabalin
69097-957	Pregabalin	Pregabalin
69097-961	Pregabalin	Pregabalin
69097-956	Pregabalin	Pregabalin
69097-954	Pregabalin	Pregabalin
69097-955	Pregabalin	Pregabalin
69238-1311	Pregabalin	Pregabalin
69238-1315	Pregabalin	Pregabalin
69238-1312	Pregabalin	Pregabalin
69238-1314	Pregabalin	Pregabalin
69238-1313	Pregabalin	Pregabalin
69238-1310	Pregabalin	Pregabalin
69238-1316	Pregabalin	Pregabalin
69238-1317	Pregabalin	Pregabalin
69539-018	Pregabalin	Pregabalin
69539-013	Pregabalin	Pregabalin
69539-015	Pregabalin	Pregabalin
69539-017	Pregabalin	Pregabalin
69539-016	Pregabalin	Pregabalin
69539-012	Pregabalin	Pregabalin
69539-014	Pregabalin	Pregabalin
69539-011	Pregabalin	Pregabalin
72205-013	Pregabalin	Pregabalin
72205-015	Pregabalin	Pregabalin
72205-017	Pregabalin	Pregabalin
72189-023	PREGABALIN	PREGABALIN
72205-012	Pregabalin	Pregabalin
72189-019	PREGABALIN	PREGABALIN
72205-014	Pregabalin	Pregabalin
72205-011	Pregabalin	Pregabalin
72189-020	PREGABALIN	PREGABALIN
72189-021	PREGABALIN	PREGABALIN
72205-018	Pregabalin	Pregabalin
72205-016	Pregabalin	Pregabalin
0071-1012	Lyrica	PREGABALIN
0071-1013	Lyrica	PREGABALIN
0071-1014	Lyrica	PREGABALIN
0071-1015	Lyrica	PREGABALIN
0071-1016	Lyrica	PREGABALIN
0071-1017	Lyrica	PREGABALIN