Home NDC 14445-174 pregabalin
Product NDC 14445-174
11-digit product format 144450174
Labeler code 14445
Product ID 14445-174_522b3d6c-10fb-4581-afb7-2e48150b6048
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pregabalin
Dosage form CAPSULE
Route ORAL
Labeler Indoco Remedies Limited
Application ANDA208113
Marketing category ANDA
Marketing start 2024-05-17
Substance PREGABALIN
Active strength 50 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208113-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 A208113-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 A208113-003 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 A208113-004 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 A208113-005 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 A208113-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 A208113-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 A208113-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 112 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-001 PREGABALIN 25MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-002 PREGABALIN 50MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-003 PREGABALIN 150MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-004 PREGABALIN 75MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-005 PREGABALIN 100MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-006 PREGABALIN 200MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-007 PREGABALIN 225MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208113-008 PREGABALIN 300MG CAPSULE / ORAL AB 2024-05-17 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 observed states.
Additional Listing Data#
Finished product Yes
Brand name base pregabalin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 55JG375S6M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483438 Internal RxNorm lookup 483440 Internal RxNorm lookup 483442 Internal RxNorm lookup 483444 Internal RxNorm lookup 483446 Internal RxNorm lookup 483448 Internal RxNorm lookup 483450 Internal RxNorm lookup 577127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 14445-174-00 pregabalin 1000 in 1 BOTTLE CAPSULE 1000 2 14445-174-10 pregabalin 100 in 1 BLISTER PACK CAPSULE 100 2 14445-174-90 pregabalin 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14445-174 PREGABALIN CAPSULE [INDOCO REMEDIES LIMITED ] 1 Current NDC, 3 package rows 20240601_0a8d9e35-46fd-4c70-bb7f-4e8b754f2794.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 14445-174-00 14445017400 1000 CAPSULE in 1 BOTTLE (14445-174-00) 1000 capsule 2024-09-06 No No Current 14445-174-10 14445017410 100 CAPSULE in 1 BLISTER PACK (14445-174-10) 100 capsule 2024-05-17 No No Current 14445-174-90 14445017490 90 CAPSULE in 1 BOTTLE (14445-174-90) 90 capsule 2024-05-17 No No Current