Application 210432

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE;ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE;ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE;ORAL300MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210432-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A210432-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A210432-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A210432-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A210432-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A210432-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A210432-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A210432-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210432-001AB
A210432-002AB
A210432-003AB
A210432-004AB
A210432-005AB
A210432-006AB
A210432-007AB
A210432-008AB

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 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210432-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A210432-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A210432-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210432-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210432-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210432-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210432-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210432-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210432-008AB16a471c1ec25d…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREGABALINPREGABALINCardinal Health 107, LLC124176c7-d8ab-4bbe-b468-3e5d12f03e442026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINREMEDYREPACK INC.1a8f13f6-0f4c-4194-ba37-b2d1a8fc49932026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINA-S Medication Solutions54a9bfb4-dcff-491d-9676-1fe1d05e004c2026-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINMajor Pharmaceuticals2420e2d7-c01a-4590-88c5-6fe5361747e92026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack335e3bcb-10a3-481b-ad95-ee9ceaa3689e2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack3ce4dfdf-e32f-40e8-9a13-e45d51539e082025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1744
PREGABALINPREGABALINBryant Ranch Prepackca861bfb-caef-4764-bad5-c95a0d0354752025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1555
PREGABALINPREGABALINBryant Ranch Prepack0101cd1f-4a95-40e9-86a8-ccde8d656e3d2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1459
PREGABALINPREGABALINBryant Ranch Prepack311e748a-7db4-4967-989b-5ed96871d99a2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1475
PREGABALINPREGABALINBryant Ranch Prepackff55a40e-4a5a-40db-87b1-7ece1d5b316f2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1476
PREGABALINPREGABALINBryant Ranch Prepack72832f05-325e-4a72-8a33-da114e39c52d2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1300
PREGABALINPREGABALINRising Pharma Holdings, Inc.dbebfa61-0685-41b4-8364-00b8d8b737142025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc8d9f1-df31-607b-e053-2995a90a028c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 80425-0027
PREGABALINPREGABALINQuality Care Products, LLCff386af0-17d3-4f95-803b-b51cb79e52952024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PregabalinPREGABALINAmerican Health Packaging59da1a16-d409-49eb-9b44-397c770060432024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack15b5e3d0-2bad-4363-99cb-e15819c41fda2024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 71335-1505
PREGABALINPREGABALINAsclemed USA, Inc.69b8a843-a3a8-4d76-8418-f482886250302020-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
ndc (product): 76420-119
ndc (product): 76420-120
ndc (product): 76420-124
ndc (product): 76420-118
ndc (product): 76420-122
ndc (product): 76420-123
ndc (product): 76420-117
ndc (product): 76420-121
PREGABALINPREGABALINProficient Rx LP4624c58f-8f77-48fa-be0f-fca4010cc8ae2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINProficient Rx LP6022939f-92a8-4cb4-9f04-f237a4d73f6f2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 120 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1459PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1459PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1459PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1459PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1475PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1475PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1475PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1476PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1476PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1476PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1476PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1505PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1505PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1505PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1555PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1555PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1555PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1555PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1744PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1744PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
71335-1744PREGABALINPREGABALINBryant Ranch PrepackANDACurrent
76420-117PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-118PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-119PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-120PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-121PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-122PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-123PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
76420-124PREGABALINPREGABALINAsclemed USA, Inc.ANDACurrent
80425-0027LyricaPregabalin 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0027PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0027PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0027PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0027PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent