Lyrica

Product NDC
43353-413
Requested package NDC
43353-413-53
11-digit product format
433530413
Labeler code
43353
Product ID
43353-413_46aed802-1b67-48f3-bf67-5a1c7a49cc46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021446
Marketing category
NDA
Marketing start
2004-12-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-41343353-413-53DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021446-001LYRICAPREGABALIN25MGCAPSULE / ORALABRLD2004-12-30
N021446-002LYRICAPREGABALIN50MGCAPSULE / ORALABRLD2004-12-30
N021446-003LYRICAPREGABALIN75MGCAPSULE / ORALABRLD2004-12-30
N021446-004LYRICAPREGABALIN100MGCAPSULE / ORALABRLD2004-12-30
N021446-005LYRICAPREGABALIN150MGCAPSULE / ORALABRLD2004-12-30
N021446-006LYRICAPREGABALIN200MGCAPSULE / ORALABRLD2004-12-30
N021446-007LYRICAPREGABALIN225MGCAPSULE / ORALABRLD2004-12-30
N021446-008LYRICAPREGABALIN300MGCAPSULE / ORALABRLD, RS2004-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
N021446-001AB
N021446-002AB
N021446-003AB
N021446-004AB
N021446-005AB
N021446-006AB
N021446-007AB
N021446-008AB

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 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021446-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021446-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021446-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021446-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021446-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021446-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021446-008AB1b8a1b40f171c…

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021446-0016001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0016197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-001RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0026001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0026197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-002RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0036001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0036197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-003RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0046001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0046197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-004RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0056001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0056197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-005RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0066001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0066197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-006RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0076001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0076197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-007RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0086001876*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-0086197819*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021446-008RE41920*PED2019-06-30Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021446-0016001876*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0016197819*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-001RE41920*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0026001876*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0026197819*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-002RE41920*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0036001876*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0036197819*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-003RE41920*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0046001876*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0046197819*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-004RE41920*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0056001876*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0056197819*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-005RE41920*PED2019-06-30Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021446-0066001876*PED2019-06-30Pediatric extension3f01610625f2…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 512 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-001NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-001PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-002NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-002PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-003NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-003PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-004NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-004PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-005NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-005PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-006NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-006PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-007NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-007PED2022-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-008NPP2022-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021446-008PED2022-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021446-001NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-001PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-002NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-002PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-003NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-003PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-004NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-004PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-005NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-005PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-006NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-006PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-007NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-007PED2022-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-008NPP2022-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021446-008PED2022-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021446-001NPP2022-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-001PED2022-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-002NPP2022-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-002PED2022-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-003NPP2022-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-003PED2022-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-004NPP2022-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021446-004PED2022-11-234b0b4de00fa7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-413-53EA - Each43353-4130862afd4-ef42-4205-81fa-fe6becf5185b12014-05-02
43353-413-70EA - Each43353-41366bc8ab7-dd1a-4570-bc9d-86f19eef463e12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-413LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC20171128_fc26526a-101c-41ca-8116-3e9e33cb1600.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LyricaPREGABALINViatris Specialty LLCd4734e7d-5079-455e-8ff5-8f4539c998a92025-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021446
application number: NDA021446
LyricaPREGABALINParke-Davis Div of Pfizer Inc60185c88-ecfd-46f9-adb9-b97c6b00a5532020-06-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021446
application number: NDA021446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-413-534335304135360 CAPSULE in 1 BOTTLE, PLASTIC (43353-413-53) 60 capsule2008-12-190000-00-00NoNoCurrent