PREGABALIN

Product NDC
43547-508
11-digit product format
435470508
Labeler code
43547
Product ID
43547-508_e7ff85eb-a068-40a7-88f0-4fa6abf6375e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA207883
Marketing category
ANDA
Marketing start
2020-06-15
Substance
PREGABALIN
Active strength
75 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
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
A207883-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2022-09-01
A207883-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2022-09-01
A207883-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2022-09-01
A207883-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2022-09-01
A207883-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2022-09-01
A207883-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2022-09-01
A207883-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2022-09-01
A207883-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2022-09-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A207883-001AB
A207883-002AB
A207883-003AB
A207883-004AB
A207883-005AB
A207883-006AB
A207883-007AB
A207883-008AB

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 6 · 216 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207883-001PREGABALIN25MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-002PREGABALIN50MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-003PREGABALIN75MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-004PREGABALIN100MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-005PREGABALIN150MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-006PREGABALIN200MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-007PREGABALIN225MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-008PREGABALIN300MGCAPSULE / ORALAB2022-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-001PREGABALIN25MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-002PREGABALIN50MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-003PREGABALIN75MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-004PREGABALIN100MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-005PREGABALIN150MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-006PREGABALIN200MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-007PREGABALIN225MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-008PREGABALIN300MGCAPSULE / ORALAB2022-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207883-001PREGABALIN25MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-002PREGABALIN50MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-003PREGABALIN75MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-004PREGABALIN100MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-005PREGABALIN150MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-006PREGABALIN200MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-007PREGABALIN225MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-008PREGABALIN300MGCAPSULE / ORALAB2022-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-001PREGABALIN25MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-002PREGABALIN50MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-003PREGABALIN75MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-004PREGABALIN100MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-005PREGABALIN150MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-006PREGABALIN200MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-007PREGABALIN225MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-008PREGABALIN300MGCAPSULE / ORALAB2022-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-001PREGABALIN25MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-002PREGABALIN50MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-003PREGABALIN75MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-004PREGABALIN100MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-005PREGABALIN150MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-006PREGABALIN200MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-007PREGABALIN225MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-008PREGABALIN300MGCAPSULE / ORALAB2022-09-01b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207883-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207883-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207883-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207883-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207883-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207883-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207883-008AB1b8a1b40f171c…

Additional Listing Data#

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

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 · 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
085db834-3735-40d9-ac67-f9dbb82390c5Available 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
43547-508-09PREGABALIN90 in 1 BOTTLECAPSULE903
43547-508-11PREGABALIN1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-508-09EA - Each43547-508cf0a9762-54c6-4ae2-a71b-ae46e7f8e06212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-508PREGABALIN CAPSULE [SOLCO HEALTHCARE US, LLC]3Current NDC, Legacy NDC, 2 package rows20240706_085db834-3735-40d9-ac67-f9dbb82390c5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREGABALINPREGABALINSolco Healthcare US, LLC085db834-3735-40d9-ac67-f9dbb82390c52026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207883
application number: ANDA207883
ndc (product): 43547-508

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483440pregabalin 150 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483446pregabalin 200 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
577127pregabalin 225 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483442pregabalin 25 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483444pregabalin 300 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483448pregabalin 50 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483450pregabalin 75 MG Oral CapsulePSN085db834-3735-40d9-ac67-f9dbb82390c53
483438pregabalin 100 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483440pregabalin 150 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483446pregabalin 200 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
577127pregabalin 225 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483442pregabalin 25 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483444pregabalin 300 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483448pregabalin 50 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53
483450pregabalin 75 MG Oral CapsuleSCD085db834-3735-40d9-ac67-f9dbb82390c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-508-094354705080990 CAPSULE in 1 BOTTLE (43547-508-09) 90 capsule2020-06-150000-00-00NoNoCurrent
43547-508-11435470508111000 CAPSULE in 1 BOTTLE (43547-508-11) 1000 capsule2020-06-150000-00-00NoNoCurrent