Pregabalin

Product NDC
70518-4579
11-digit product format
705184579
Labeler code
70518
Product ID
70518-4579_5bafca7c-cb3c-4a03-e063-6394a90a7543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206942
Marketing category
ANDA
Marketing start
2026-03-04
Substance
PREGABALIN
Active strength
75 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 43.

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.

Product history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A206942-001PREGABALIN25MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-002PREGABALIN50MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-003PREGABALIN75MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-004PREGABALIN100MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-005PREGABALIN150MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-006PREGABALIN200MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-007PREGABALIN225MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-008PREGABALIN300MGCAPSULE / ORALAB2025-02-21caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206942-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A206942-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A206942-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206942-008AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN75 mg/1

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
70518-4579-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE902

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
PregabalinPREGABALINTorrent Pharmaceuticals Limiteda062e78a-16ff-4d83-b700-0badb7d812d52026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206942
application number: ANDA206942

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN4ccb0d75-d7d9-471c-8737-8552e9e57efa2
483450pregabalin 75 MG Oral CapsuleSCD4ccb0d75-d7d9-471c-8737-8552e9e57efa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4579-07051845790090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4579-0) 90 capsule2026-03-04NoNoCurrent