FDA.reportPublic FDA data

pregabalin

Product NDC
43598-297
11-digit product format
435980297
Labeler code
43598
Product ID
43598-297_4a1e5038-d049-606f-c087-48bc353a8a69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA209664
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
225 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
A209664-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A209664-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A209664-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A209664-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A209664-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A209664-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A209664-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A209664-008PREGABALINPREGABALIN300MGCAPSULE / 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
A209664-001AB
A209664-002AB
A209664-003AB
A209664-004AB
A209664-005AB
A209664-006AB
A209664-007AB
A209664-008AB

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 UTC2026-02A209664-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209664-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-008PREGABALIN300MGCAPSULE / 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 UTC2026-02A209664-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209664-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209664-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209664-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209664-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209664-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209664-008AB1b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN225 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
ceed457b-8f43-4021-fd70-071c96e09470Available 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
43598-297-05pregabalin500 in 1 BOTTLECAPSULE50013
43598-297-66pregabalin5 in 1 CARTONCAPSULE513
43598-297-78pregabalin10 in 1 CARTONCAPSULE1013
43598-297-79pregabalin10 in 1 BLISTER PACKCAPSULE1013
43598-297-90pregabalin90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-297-90EA - Each43598-29753e50f06-9854-4f60-8f01-e172052a50dc12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-297PREGABALIN CAPSULE [DR.REDDYS LABORATORIES INC]12Current NDC, Legacy NDC, 5 package rows20240228_ceed457b-8f43-4021-fd70-071c96e09470.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
pregabalinPREGABALINDr.Reddys Laboratories Incceed457b-8f43-4021-fd70-071c96e094702025-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209664
application number: ANDA209664
ndc (product): 43598-297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483440pregabalin 150 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483446pregabalin 200 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
577127pregabalin 225 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483442pregabalin 25 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483444pregabalin 300 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483448pregabalin 50 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483450pregabalin 75 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483438pregabalin 100 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483440pregabalin 150 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483446pregabalin 200 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
577127pregabalin 225 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483442pregabalin 25 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483444pregabalin 300 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483448pregabalin 50 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483450pregabalin 75 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-297-0543598029705500 CAPSULE in 1 BOTTLE (43598-297-05) 500 capsule2019-07-190000-00-00NoNoCurrent
43598-297-66435980297665 BLISTER PACK in 1 CARTON (43598-297-66) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79) 5 blister pack2019-07-190000-00-00NoNoCurrent
43598-297-784359802977810 BLISTER PACK in 1 CARTON (43598-297-78) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79) 10 blister pack2019-07-190000-00-00NoNoCurrent
43598-297-794359802977910 in 1 BLISTER PACKHistorical
43598-297-904359802979090 CAPSULE in 1 BOTTLE (43598-297-90) 90 capsule2019-07-190000-00-00NoNoCurrent