Home NDC 70518-4579 Pregabalin
Product NDC 70518-4579
11-digit product format 705184579
Labeler code 70518
Product ID 70518-4579_5bafca7c-cb3c-4a03-e063-6394a90a7543
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA206942
Marketing category ANDA
Marketing start 2026-03-04
Substance PREGABALIN
Active strength 75 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206942-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 A206942-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 A206942-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 A206942-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 A206942-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 A206942-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 A206942-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 A206942-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21
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 2 · 56 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 2026-09-14 22:38:34 2026-08 A206942-001 PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-002 PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-003 PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-004 PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-005 PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-006 PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-007 PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206942-008 PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206942-001 PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-002 PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-003 PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-004 PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-005 PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-006 PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-007 PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206942-008 PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206942-001 PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-002 PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-003 PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-004 PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-005 PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-006 PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-007 PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206942-008 PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-001 PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-002 PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-003 PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-004 PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-005 PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-006 PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-007 PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206942-008 PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206942-001 PREGABALIN 25MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-002 PREGABALIN 50MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-003 PREGABALIN 75MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-004 PREGABALIN 100MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-005 PREGABALIN 150MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-006 PREGABALIN 200MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-007 PREGABALIN 225MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206942-008 PREGABALIN 300MG CAPSULE / ORAL AB 2025-02-21 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pregabalin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 75 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4579-0 Pregabalin 90 in 1 BOTTLE, PLASTIC CAPSULE 90 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pregabalin PREGABALIN Torrent Pharmaceuticals Limited a062e78a-16ff-4d83-b700-0badb7d812d5 2026-03-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 206942 application number: ANDA206942
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4579-0 70518457900 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4579-0) 90 capsule 2026-03-04 No No Current