PREGABALIN

Product NDC
72189-021
11-digit product format
721890021
Labeler code
72189
Product ID
72189-021_2c4e8635-a2d3-601d-e063-6294a90aaee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-30
Substance
PREGABALIN
Active strength
75 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-021-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-021-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-021-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-021-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-021-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-021-900efc9e666f02…f202fb6c5f17…

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
A208677-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A208677-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A208677-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A208677-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A208677-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A208677-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A208677-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A208677-008PREGABALINPREGABALIN300MGCAPSULE / 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
A208677-001AB
A208677-002AB
A208677-003AB
A208677-004AB
A208677-005AB
A208677-006AB
A208677-007AB
A208677-008AB

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 UTC2026-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-008PREGABALIN300MGCAPSULE / 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 UTC2026-02A208677-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-008AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
PREGABALIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN75 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483450Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ee9e08f-cf87-599c-e053-2995a90a563cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-021-30PREGABALIN30 in 1 BOTTLECAPSULE304
72189-021-60PREGABALIN60 in 1 BOTTLECAPSULE604
72189-021-90PREGABALIN90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-021-30EA - Each72189-0214e841d5b-8836-4a41-a6bd-b3bc09728e8b12022-11-07
72189-021-60EA - Each72189-02191012262-0f8e-4f3a-8533-b2b7e466f81212022-11-07
72189-021-90EA - Each72189-021f880e46c-e928-4b95-90c3-afab7fbd62b712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-021PREGABALIN CAPSULE [DIRECT_RX]4Current NDC, Legacy NDC, 3 package rows20250123_8ee9e08f-cf87-599c-e053-2995a90a563c.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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINSt. Mary's Medical Park Pharmacyfc5dd378-950f-949b-e053-6394a90a3ca22026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY923743f0-f557-9143-e053-2a95a90a21ae2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack45abbcb4-6a38-469d-9671-24b2c25e5b182026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf9ede-5e8b-b5e1-e063-6394a90ac7f32026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d53c8e2-f03f-0f5b-e063-6294a90a23c62026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ef59b1c-1273-5e54-e063-6294a90a0ec92026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack1a8d8292-1f94-46da-bade-8c40542013432026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackb977269a-7d62-44a2-bd0d-11c54b8728362026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd01590e-5b90-4a77-ad5f-76adabf3c32e2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d63908b-96be-554c-e063-6394a90af5102026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack8a7acea4-108d-40d2-a2a7-36088be972482026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack025c3adb-5f6b-45f5-a4c6-cea8e57102e32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack2ceccc4d-97e2-4eb0-841f-23609187710c2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack247aedca-ae27-44c6-b32c-c95d264545662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepacke1ed81bc-1597-4bc5-80cd-09977a154e4b2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd568ede-dac7-4910-bb18-65fb00f2636e2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINProficient Rx LP32789571-a566-46fa-ba41-bd3c86276ecf2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackc60f6b1e-7a24-41b2-8435-e20583a732c62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN8ee9e08f-cf87-599c-e053-2995a90a563c4
483450pregabalin 75 MG Oral CapsuleSCD8ee9e08f-cf87-599c-e053-2995a90a563c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-021-307218900213030 CAPSULE in 1 BOTTLE (72189-021-30) 30 capsule2019-07-300000-00-00NoNoCurrent
72189-021-607218900216060 CAPSULE in 1 BOTTLE (72189-021-60) 60 capsule2019-07-300000-00-00NoNoCurrent
72189-021-907218900219090 CAPSULE in 1 BOTTLE (72189-021-90) 90 capsule2019-07-300000-00-00NoNoCurrent