PREGABALIN

Product NDC
70518-2290
Requested package NDC
70518-2290-0
11-digit product format
705182290
Labeler code
70518
Product ID
70518-2290_c7b8e39f-4f68-cdca-e053-2a95a90a32ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-08-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
225 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage70518-229070518-2290-0DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 8 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210432-001PREGABALIN25MGCAPSULE / 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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…

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 UTC2026-02A210432-001AB1011fe1cb6892…
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210432-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210432-008AB1b8a1b40f171c…

FDA-Initiated Inactive NDC Indexing#

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
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
PREGABALINPREGABALINBryant Ranch Prepackca861bfb-caef-4764-bad5-c95a0d0354752025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack0101cd1f-4a95-40e9-86a8-ccde8d656e3d2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack311e748a-7db4-4967-989b-5ed96871d99a2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepackff55a40e-4a5a-40db-87b1-7ece1d5b316f2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINBryant Ranch Prepack72832f05-325e-4a72-8a33-da114e39c52d2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINRising Pharma Holdings, Inc.dbebfa61-0685-41b4-8364-00b8d8b737142025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
PREGABALINPREGABALINA-S Medication Solutions54a9bfb4-dcff-491d-9676-1fe1d05e004c2025-05-15Warnings, 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
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
PREGABALINPREGABALINAsclemed USA, Inc.69b8a843-a3a8-4d76-8418-f482886250302020-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210432
application number: ANDA210432
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2290-07051822900090 CAPSULE in 1 BOTTLE, PLASTIC (70518-2290-0) 90 capsule2019-08-300000-00-00NoNoCurrent