pregabalin

Product NDC
14445-173
11-digit product format
144450173
Labeler code
14445
Product ID
14445-173_522b3d6c-10fb-4581-afb7-2e48150b6048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA208113
Marketing category
ANDA
Marketing start
2024-05-17
Substance
PREGABALIN
Active strength
25 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
A208113-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2024-05-17
A208113-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2024-05-17
A208113-003PREGABALINPREGABALIN150MGCAPSULE / ORALAB2024-05-17
A208113-004PREGABALINPREGABALIN75MGCAPSULE / ORALAB2024-05-17
A208113-005PREGABALINPREGABALIN100MGCAPSULE / ORALAB2024-05-17
A208113-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2024-05-17
A208113-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2024-05-17
A208113-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2024-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208113-001AB
A208113-002AB
A208113-003AB
A208113-004AB
A208113-005AB
A208113-006AB
A208113-007AB
A208113-008AB

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 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208113-001PREGABALIN25MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-002PREGABALIN50MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-003PREGABALIN150MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-004PREGABALIN75MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-005PREGABALIN100MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-006PREGABALIN200MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-007PREGABALIN225MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-008PREGABALIN300MGCAPSULE / ORALAB2024-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-001PREGABALIN25MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-002PREGABALIN50MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-003PREGABALIN150MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-004PREGABALIN75MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-005PREGABALIN100MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-006PREGABALIN200MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-007PREGABALIN225MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-008PREGABALIN300MGCAPSULE / ORALAB2024-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208113-001PREGABALIN25MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-002PREGABALIN50MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-003PREGABALIN150MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-004PREGABALIN75MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-005PREGABALIN100MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-006PREGABALIN200MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-007PREGABALIN225MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-008PREGABALIN300MGCAPSULE / ORALAB2024-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-001PREGABALIN25MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-002PREGABALIN50MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-003PREGABALIN150MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-004PREGABALIN75MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-005PREGABALIN100MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-006PREGABALIN200MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-007PREGABALIN225MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-008PREGABALIN300MGCAPSULE / ORALAB2024-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-001PREGABALIN25MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-002PREGABALIN50MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-003PREGABALIN150MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-004PREGABALIN75MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-005PREGABALIN100MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-006PREGABALIN200MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-007PREGABALIN225MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-008PREGABALIN300MGCAPSULE / ORALAB2024-05-17b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208113-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208113-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208113-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208113-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208113-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208113-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208113-008AB1b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN25 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
0a8d9e35-46fd-4c70-bb7f-4e8b754f2794Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-173-90pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-173PREGABALIN CAPSULE [INDOCO REMEDIES LIMITED ]1Current NDC, 1 package rows20240601_0a8d9e35-46fd-4c70-bb7f-4e8b754f2794.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
pregabalinPREGABALINIndoco Remedies Limited0a8d9e35-46fd-4c70-bb7f-4e8b754f27942025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208113
application number: ANDA208113
ndc (product): 14445-173

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483440pregabalin 150 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483446pregabalin 200 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
577127pregabalin 225 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483442pregabalin 25 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483444pregabalin 300 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483448pregabalin 50 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483450pregabalin 75 MG Oral CapsulePSN0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483438pregabalin 100 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483440pregabalin 150 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483446pregabalin 200 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
577127pregabalin 225 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483442pregabalin 25 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483444pregabalin 300 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483448pregabalin 50 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942
483450pregabalin 75 MG Oral CapsuleSCD0a8d9e35-46fd-4c70-bb7f-4e8b754f27942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-173-901444501739090 CAPSULE in 1 BOTTLE (14445-173-90) 90 capsule2024-05-17NoNoCurrent