Pregabalin

Product NDC
80425-0166
11-digit product format
804250166
Labeler code
80425
Product ID
80425-0166_ed252a00-715a-6647-e053-2a95a90a41d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212865
Marketing category
ANDA
Marketing start
2020-03-31
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80425-0166DDiscontinued by firm2026-08-07
excluded packagepackage80425-016680425-0166-3DDiscontinued by firm2026-08-07

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 · 4 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 packagepackage80425-0166-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80425-0166-3f5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212865-001PREGABALINPREGABALIN50MGCAPSULE / ORALAB2020-03-20
A212865-002PREGABALINPREGABALIN75MGCAPSULE / ORALAB2020-03-20
A212865-003PREGABALINPREGABALIN100MGCAPSULE / ORALAB2020-03-20
A212865-004PREGABALINPREGABALIN150MGCAPSULE / ORALAB2020-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A212865-001AB
A212865-002AB
A212865-003AB
A212865-004AB

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 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212865-001PREGABALIN50MGCAPSULE / ORALAB2020-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-002PREGABALIN75MGCAPSULE / ORALAB2020-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-003PREGABALIN100MGCAPSULE / ORALAB2020-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-004PREGABALIN150MGCAPSULE / ORALAB2020-03-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212865-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212865-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212865-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212865-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212865-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212865-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212865-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212865-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212865-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212865-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212865-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212865-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212865-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0166-3EA - Each80425-016668d1ad78-68ae-478d-9a00-a69f5f5391ca12023-04-07

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINChartwell RX, LLC13d03119-e49b-482e-b5f9-d40dc3f4862e2025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212865
application number: ANDA212865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0166-38042501660390 CAPSULE in 1 BOTTLE (80425-0166-3) 90 capsule2020-03-310000-00-00NoNoCurrent