Pregabalin

Product NDC
76420-097
Requested package NDC
76420-097-30
11-digit product format
764200097
Labeler code
76420
Product ID
76420-097_ead3b1c9-5c7d-457b-e053-2995a90a71ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
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 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
A208677-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A208677-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A208677-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A208677-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A208677-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A208677-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A208677-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A208677-008PREGABALINPREGABALIN300MGCAPSULE / 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
A208677-001AB
A208677-002AB
A208677-003AB
A208677-004AB
A208677-005AB
A208677-006AB
A208677-007AB
A208677-008AB

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 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208677-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A208677-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008AB16a471c1ec25d…

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
2026-12-31

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
3d2464fb-b3ac-496e-b8a5-c2e8a902ce29Available 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
76420-097-30Pregabalin30 in 1 BOTTLECAPSULE302
76420-097-60Pregabalin60 in 1 BOTTLECAPSULE602
76420-097-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-097-30EA - Each76420-097bb4171c4-56a9-4f9d-8780-f9f49427848c12021-01-08
76420-097-60EA - Each76420-097cbfb8d45-ada2-4f04-b818-9f762afb982b12021-01-08
76420-097-90EA - Each76420-0977bf446a8-2918-420e-8223-91faf4985f7512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-097PREGABALIN CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20221013_3d2464fb-b3ac-496e-b8a5-c2e8a902ce29.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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacyfc5dd378-950f-949b-e053-6394a90a3ca22026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY923743f0-f557-9143-e053-2a95a90a21ae2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack45abbcb4-6a38-469d-9671-24b2c25e5b182026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf9ede-5e8b-b5e1-e063-6394a90ac7f32026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d53c8e2-f03f-0f5b-e063-6294a90a23c62026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ef59b1c-1273-5e54-e063-6294a90a0ec92026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack1a8d8292-1f94-46da-bade-8c40542013432026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackb977269a-7d62-44a2-bd0d-11c54b8728362026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd01590e-5b90-4a77-ad5f-76adabf3c32e2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d63908b-96be-554c-e063-6394a90af5102026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack8a7acea4-108d-40d2-a2a7-36088be972482026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack025c3adb-5f6b-45f5-a4c6-cea8e57102e32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack2ceccc4d-97e2-4eb0-841f-23609187710c2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack247aedca-ae27-44c6-b32c-c95d264545662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepacke1ed81bc-1597-4bc5-80cd-09977a154e4b2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackfd568ede-dac7-4910-bb18-65fb00f2636e2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINProficient Rx LP32789571-a566-46fa-ba41-bd3c86276ecf2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsulePSN3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483438pregabalin 100 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483440pregabalin 150 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483446pregabalin 200 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
577127pregabalin 225 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483442pregabalin 25 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483444pregabalin 300 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483448pregabalin 50 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292
483450pregabalin 75 MG Oral CapsuleSCD3d2464fb-b3ac-496e-b8a5-c2e8a902ce292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-097-307642000973030 CAPSULE in 1 BOTTLE (76420-097-30) 30 capsule2020-06-170000-00-00NoNoCurrent