PREGABALIN

Product NDC
0904-7001
11-digit product format
009047001
Labeler code
0904
Product ID
0904-7001_ce6f3554-3f28-4d2e-8f32-e0893f1f43a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
PREGABALIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55JG375S6MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483438Internal RxNorm lookup
483440Internal RxNorm lookup
483442Internal RxNorm lookup
483444Internal RxNorm lookup
483446Internal RxNorm lookup
483448Internal RxNorm lookup
483450Internal RxNorm lookup
577127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2420e2d7-c01a-4590-88c5-6fe5361747e9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7001-61PREGABALIN100 in 1 CARTONCAPSULE1007
0904-7001-61PREGABALIN1 in 1 BLISTER PACKCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7001-61EA - Each0904-7001f0223e23-4f79-4d82-b601-c3f69c62ff9012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7001PREGABALIN CAPSULE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250206_2420e2d7-c01a-4590-88c5-6fe5361747e9.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 · 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
ndc (product): 0904-7001
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483440pregabalin 150 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483446pregabalin 200 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
577127pregabalin 225 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483442pregabalin 25 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483444pregabalin 300 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483448pregabalin 50 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483450pregabalin 75 MG Oral CapsulePSN2420e2d7-c01a-4590-88c5-6fe5361747e97
483438pregabalin 100 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483440pregabalin 150 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483446pregabalin 200 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
577127pregabalin 225 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483442pregabalin 25 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483444pregabalin 300 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483448pregabalin 50 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483450pregabalin 75 MG Oral CapsuleSCD2420e2d7-c01a-4590-88c5-6fe5361747e97
483438pregabalin 100 MG Oral CapsulePSN124176c7-d8ab-4bbe-b468-3e5d12f03e446
483448pregabalin 50 MG Oral CapsulePSN124176c7-d8ab-4bbe-b468-3e5d12f03e446
483450pregabalin 75 MG Oral CapsulePSN124176c7-d8ab-4bbe-b468-3e5d12f03e446
483438pregabalin 100 MG Oral CapsuleSCD124176c7-d8ab-4bbe-b468-3e5d12f03e446
483448pregabalin 50 MG Oral CapsuleSCD124176c7-d8ab-4bbe-b468-3e5d12f03e446
483450pregabalin 75 MG Oral CapsuleSCD124176c7-d8ab-4bbe-b468-3e5d12f03e446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7001-6100904700161100 BLISTER PACK in 1 CARTON (0904-7001-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2019-07-190000-00-00NoNoCurrent