Home NDC 60760-682 Pregabalin
Product NDC 60760-682
11-digit product format 607600682
Labeler code 60760
Product ID 60760-682_557ae326-fa0b-3a4e-e063-6394a90acbf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA207799
Marketing category ANDA
Marketing start 2025-05-13
Substance PREGABALIN
Active strength 150 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 A207799-001 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 A207799-002 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 A207799-003 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 A207799-004 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 A207799-005 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 A207799-006 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 A207799-007 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 A207799-008 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30
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 · 324 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 A207799-001 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-002 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-003 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-004 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-005 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-006 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-007 PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207799-008 PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207799-001 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-002 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-003 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-004 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-005 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-006 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-007 PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207799-008 PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207799-001 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-002 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-003 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-004 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-005 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-006 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-007 PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207799-008 PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-001 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-002 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-003 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-004 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-005 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-006 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-007 PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207799-008 PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207799-001 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-002 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-003 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-004 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-005 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-006 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-007 PREGABALIN 25MG CAPSULE / ORAL AB 2019-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207799-008 PREGABALIN 50MG CAPSULE / ORAL AB 2019-09-30 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 324 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 150 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 483440 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 60760-682-30 Pregabalin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60760-682-30 60760068230 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-682-30) 30 capsule 2025-05-13 No No Current