Pregabalin

Product NDC
0093-7625
11-digit product format
000937625
Labeler code
0093
Product ID
0093-7625_af869238-9611-433f-bfa2-75337d4413b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091224
Marketing category
ANDA
Marketing start
2019-07-22
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7625DDiscontinued by firm2026-08-17
excluded packagepackage0093-76250093-7625-98DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7625-98d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7625-98f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7625-982ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7625-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7625-98cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7625-98cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7625-98302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7625-98ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7625-980efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7625-98ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7625-98367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7625-98557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091224-001PREGABALINPREGABALIN75MGCAPSULE / ORAL2019-07-19
A091224-002PREGABALINPREGABALIN100MGCAPSULE / ORAL2019-07-19
A091224-003PREGABALINPREGABALIN150MGCAPSULE / ORAL2019-07-19
A091224-004PREGABALINPREGABALIN200MGCAPSULE / ORAL2019-07-19
A091224-005PREGABALINPREGABALIN225MGCAPSULE / ORAL2019-07-19
A091224-006PREGABALINPREGABALIN300MGCAPSULE / ORAL2019-07-19

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-005PREGABALIN225MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091224-006PREGABALIN300MGCAPSULE / ORAL2019-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091224-001PREGABALIN75MGCAPSULE / ORAL2019-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091224-002PREGABALIN100MGCAPSULE / ORAL2019-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091224-003PREGABALIN150MGCAPSULE / ORAL2019-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091224-004PREGABALIN200MGCAPSULE / ORAL2019-07-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091224-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091224-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091224-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091224-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091224-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091224-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091224-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091224-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091224-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091224-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091224-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091224-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091224-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091224-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091224-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091224-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091224-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091224-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091224-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091224-004AB14b0b4de00fa7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7625-98EA - Each0093-76251281258d-1798-4739-9a75-b879b828f3a612019-08-06