Home NDC 69097-684 PREGABALIN capsules, CV
Product NDC 69097-684
11-digit product format 690970684
Labeler code 69097
Product ID 69097-684_22a469ee-1346-4abb-84f1-4c2caf26437b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN capsules, CV
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Application ANDA212280
Marketing category ANDA
Marketing start 2020-01-10
Substance PREGABALIN
Active strength 225 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 42 .
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 A212280-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 A212280-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 A212280-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 A212280-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 A212280-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 A212280-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 A212280-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 A212280-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL 2020-01-10
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 8 · 304 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 2026-08-18 06:07:40 2026-07 A212280-001 PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-002 PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-003 PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-004 PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-005 PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-006 PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-007 PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212280-008 PREGABALIN 300MG CAPSULE / ORAL 2020-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212280-001 PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-002 PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-003 PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-004 PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-005 PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-006 PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-007 PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212280-008 PREGABALIN 300MG CAPSULE / ORAL 2020-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-001 PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-002 PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-003 PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-004 PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-005 PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-006 PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-007 PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212280-008 PREGABALIN 300MG CAPSULE / ORAL 2020-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212280-001 PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-002 PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-003 PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-004 PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-005 PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-006 PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-007 PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212280-008 PREGABALIN 300MG CAPSULE / ORAL 2020-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-001 PREGABALIN 25MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-002 PREGABALIN 50MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-003 PREGABALIN 75MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-004 PREGABALIN 100MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-005 PREGABALIN 150MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-006 PREGABALIN 200MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-007 PREGABALIN 225MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212280-008 PREGABALIN 300MG CAPSULE / ORAL 2020-01-10 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 184 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PREGABALIN capsules, CV
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 225 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 69097-684-02 PREGABALIN capsules, CV 30 in 1 BOTTLE CAPSULE 30 9 69097-684-05 PREGABALIN capsules, CV 90 in 1 BOTTLE CAPSULE 90 9 69097-684-12 PREGABALIN capsules, CV 500 in 1 BOTTLE CAPSULE 500 9 69097-684-19 PREGABALIN capsules, CV 10 in 1 BLISTER PACK CAPSULE 10 9 69097-684-21 PREGABALIN capsules, CV 100 in 1 CARTON CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-684 PREGABALIN CAPSULES, CV CAPSULE [CIPLA USA INC.] 7 Current NDC, Legacy NDC, 5 package rows 20211123_7d93359c-1849-430d-a922-21d42932d0f3.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 Marketing end Sample Exclude flag Status 69097-684-02 69097068402 30 CAPSULE in 1 BOTTLE (69097-684-02) 30 capsule 2020-01-10 0000-00-00 No No Current 69097-684-05 69097068405 90 CAPSULE in 1 BOTTLE (69097-684-05) 90 capsule 2020-01-10 0000-00-00 No No Current 69097-684-12 69097068412 500 CAPSULE in 1 BOTTLE (69097-684-12) 500 capsule 2020-01-10 0000-00-00 No No Current 69097-684-19 69097068419 10 in 1 BLISTER PACK Historical 69097-684-21 69097068421 100 BLISTER PACK in 1 CARTON (69097-684-21) > 10 CAPSULE in 1 BLISTER PACK (69097-684-19) 100 blister pack 2020-01-10 0000-00-00 No No Current