Home NDC 60760-751 Pregabalin
Product NDC 60760-751
11-digit product format 607600751
Labeler code 60760
Product ID 60760-751_550bfd3b-1c3d-e53f-e063-6294a90a80c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA209357
Marketing category ANDA
Marketing start 2025-02-12
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 A209357-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 A209357-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 A209357-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 A209357-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 A209357-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 A209357-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 A209357-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 A209357-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19
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 9 · 336 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 A209357-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209357-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209357-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209357-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209357-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209357-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209357-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209357-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209357-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 336 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
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483450 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 60760-751-30 Pregabalin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2 60760-751-60 Pregabalin 60 in 1 BOTTLE, PLASTIC CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-751 PREGABALIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] 2 Current NDC, 2 package rows 20250508_2e6e6f9c-a14c-2d75-e063-6294a90a827e.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 2 of 2 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pregabalin PREGABALIN Advanced Rx of Tennessee, LLC afd59273-75d1-5f33-e053-2995a90ab25f 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209357 application number: ANDA209357 Pregabalin PREGABALIN Aphena Pharma Solutions - Tennessee, LLC 8bb9495e-1354-4a70-baa5-9b80eb3518c8 2024-07-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209357 application number: ANDA209357 Pregabalin PREGABALIN Aphena Pharma Solutions - Tennessee, LLC 4ed3e73c-13e7-4646-874d-276b6c75d2c9 2024-02-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209357 application number: ANDA209357 Pregabalin PREGABALIN Aphena Pharma Solutions - Tennessee, LLC d2a98872-1a52-47e1-b4bd-0ff7d6272a92 2023-12-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209357 application number: ANDA209357
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60760-751-30 60760075130 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-751-30) 30 capsule 2025-05-07 No No Current 60760-751-60 60760075160 60 CAPSULE in 1 BOTTLE, PLASTIC (60760-751-60) 60 capsule 2025-02-12 No No Current