FDA.reportPublic FDA data

Pregabalin

Product NDC
13668-361
11-digit product format
136680361
Labeler code
13668
Product ID
13668-361_f28a120a-aea5-45b9-84f7-06f48f41bc03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA206942
Marketing category
ANDA
Marketing start
2025-05-19
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
A206942-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2025-02-21
A206942-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2025-02-21
A206942-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2025-02-21
A206942-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2025-02-21
A206942-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2025-02-21
A206942-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2025-02-21
A206942-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2025-02-21
A206942-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2025-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206942-001AB
A206942-002AB
A206942-003AB
A206942-004AB
A206942-005AB
A206942-006AB
A206942-007AB
A206942-008AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206942-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206942-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206942-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206942-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206942-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206942-008AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-006AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-007AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206942-008AB1a50c72e98297…

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
a062e78a-16ff-4d83-b700-0badb7d812d5Available 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
13668-361-01Pregabalin100 in 1 BOTTLECAPSULE10012
13668-361-05Pregabalin500 in 1 BOTTLECAPSULE50012
13668-361-30Pregabalin30 in 1 BOTTLECAPSULE3012
13668-361-60Pregabalin60 in 1 BOTTLECAPSULE6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-361-05EA - Each13668-36159a183c1-4913-4ce0-b9d0-9ba440fa9a4c12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-361PREGABALIN CAPSULE [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, 4 package rows20250520_a062e78a-16ff-4d83-b700-0badb7d812d5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINTorrent Pharmaceuticals Limiteda062e78a-16ff-4d83-b700-0badb7d812d52026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206942
application number: ANDA206942
ndc (product): 13668-361
PregabalinPREGABALINREMEDYREPACK INC.4ccb0d75-d7d9-471c-8737-8552e9e57efa2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206942
application number: ANDA206942

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483440pregabalin 150 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483446pregabalin 200 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
577127pregabalin 225 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483442pregabalin 25 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483444pregabalin 300 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483448pregabalin 50 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483450pregabalin 75 MG Oral CapsulePSNa062e78a-16ff-4d83-b700-0badb7d812d512
483438pregabalin 100 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483440pregabalin 150 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483446pregabalin 200 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
577127pregabalin 225 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483442pregabalin 25 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483444pregabalin 300 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483448pregabalin 50 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512
483450pregabalin 75 MG Oral CapsuleSCDa062e78a-16ff-4d83-b700-0badb7d812d512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-361-0113668036101100 CAPSULE in 1 BOTTLE (13668-361-01) 100 capsule2025-05-19NoNoCurrent
13668-361-0513668036105500 CAPSULE in 1 BOTTLE (13668-361-05) 500 capsule2025-05-19NoNoCurrent
13668-361-301366803613030 CAPSULE in 1 BOTTLE (13668-361-30) 30 capsule2025-05-19NoNoCurrent
13668-361-601366803616060 CAPSULE in 1 BOTTLE (13668-361-60) 60 capsule2025-05-19NoNoCurrent