Pregabalin

Product NDC
70518-2483
Requested package NDC
70518-2483-0
11-digit product format
705182483
Labeler code
70518
Product ID
70518-2483_dbfc9db9-b3fd-8109-e053-2a95a90abb8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209743
Marketing category
ANDA
Marketing start
2019-12-13
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
150 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage70518-248370518-2483-0DDiscontinued by firm2026-09-09

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 · 11 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…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209743-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A209743-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A209743-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A209743-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A209743-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A209743-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A209743-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A209743-008PREGABALINPREGABALIN300MGCAPSULE / 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
A209743-001AB
A209743-002AB
A209743-003AB
A209743-004AB
A209743-005AB
A209743-006AB
A209743-007AB
A209743-008AB

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
2026-08-18 06:07:402026-07A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209743-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008AB1fd3edfee7708…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3099759f-cb24-40e8-b482-9388c38c73b92025-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINProficient Rx LPa17f03ea-9375-48fe-be32-f8df509f5fba2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2483-07051824830090 CAPSULE in 1 BOTTLE, PLASTIC (70518-2483-0) 90 capsule2019-12-130000-00-00NoNoCurrent