Pregabalin

Product NDC
65862-761
Requested package NDC
65862-761-49
11-digit product format
658620761
Labeler code
65862
Product ID
65862-761_03c24a38-f80a-4acb-ab38-c747c13125d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205321
Marketing category
ANDA
Marketing start
2023-03-29
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-76165862-761-49UNFINISHEDActive or certified unfinished drug listing2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…

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
A205321-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2023-03-29
A205321-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2023-03-29
A205321-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2023-03-29
A205321-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2023-03-29
A205321-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2023-03-29
A205321-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2023-03-29
A205321-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2023-03-29
A205321-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2023-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205321-001AB
A205321-002AB
A205321-003AB
A205321-004AB
A205321-005AB
A205321-006AB
A205321-007AB
A205321-008AB

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 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205321-001PREGABALIN25MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-002PREGABALIN50MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-003PREGABALIN75MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-004PREGABALIN100MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-005PREGABALIN150MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-006PREGABALIN200MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-007PREGABALIN225MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-09-14 22:38:342026-08A205321-008PREGABALIN300MGCAPSULE / ORALAB2023-03-2984e616aacf4f…
2026-08-18 06:07:402026-07A205321-001PREGABALIN25MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-002PREGABALIN50MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-003PREGABALIN75MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-004PREGABALIN100MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-005PREGABALIN150MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-006PREGABALIN200MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-007PREGABALIN225MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-008PREGABALIN300MGCAPSULE / ORALAB2023-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205321-001PREGABALIN25MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-002PREGABALIN50MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-003PREGABALIN75MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-004PREGABALIN100MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-005PREGABALIN150MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-006PREGABALIN200MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-007PREGABALIN225MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-008PREGABALIN300MGCAPSULE / ORALAB2023-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-001PREGABALIN25MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-002PREGABALIN50MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-003PREGABALIN75MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-004PREGABALIN100MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-005PREGABALIN150MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-006PREGABALIN200MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-007PREGABALIN225MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-008PREGABALIN300MGCAPSULE / ORALAB2023-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205321-001PREGABALIN25MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-002PREGABALIN50MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-003PREGABALIN75MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-004PREGABALIN100MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-005PREGABALIN150MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-006PREGABALIN200MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-007PREGABALIN225MGCAPSULE / ORALAB2023-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-008PREGABALIN300MGCAPSULE / ORALAB2023-03-296a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205321-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A205321-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A205321-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205321-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205321-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205321-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205321-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205321-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205321-008AB16a471c1ec25d…

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
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
11034861-eef2-4996-8082-afc3c1769171Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-761-01Pregabalin100 in 1 BOTTLECAPSULE1004
65862-761-05Pregabalin500 in 1 BOTTLECAPSULE5004
65862-761-10Pregabalin10 in 1 BLISTER PACKCAPSULE104
65862-761-78Pregabalin10 in 1 CARTONCAPSULE104
65862-761-90Pregabalin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-761-90EA - Each65862-7610cf3244c-a358-4b16-98b2-337f9fcc5ed212023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-761PREGABALIN CAPSULE [AUROBINDO PHARMA LIMITED]3Current NDC, 5 package rows20250528_11034861-eef2-4996-8082-afc3c1769171.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINClinical Solutions Wholesale, LLC93c2fe8b-67d7-4a15-8790-5595e158b3ab2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321
PregabalinPREGABALINCoupler LLC5383c0de-0c85-f702-e063-6294a90a1d8d2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321
PregabalinPREGABALINAurobindo Pharma Limited11034861-eef2-4996-8082-afc3c17691712026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321
ndc (product): 65862-761
PregabalinPREGABALINCoupler LLC463d31dd-ff14-cc89-e063-6294a90a2ea92026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321
PregabalinPREGABALINCoupler LLC2ccc641e-6859-046e-e063-6294a90a50172025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC29b91992-c853-a57d-e063-6394a90ab3652024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205321
application number: ANDA205321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483440pregabalin 150 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483446pregabalin 200 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
577127pregabalin 225 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483442pregabalin 25 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483444pregabalin 300 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483448pregabalin 50 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483450pregabalin 75 MG Oral CapsulePSN11034861-eef2-4996-8082-afc3c17691714
483438pregabalin 100 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483440pregabalin 150 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483446pregabalin 200 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
577127pregabalin 225 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483442pregabalin 25 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483444pregabalin 300 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483448pregabalin 50 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483450pregabalin 75 MG Oral CapsuleSCD11034861-eef2-4996-8082-afc3c17691714
483438pregabalin 100 MG Oral CapsulePSN463d31dd-ff14-cc89-e063-6294a90a2ea92
483438pregabalin 100 MG Oral CapsuleSCD463d31dd-ff14-cc89-e063-6294a90a2ea92
483438pregabalin 100 MG Oral CapsulePSN29b91992-c853-a57d-e063-6394a90ab3651
483438pregabalin 100 MG Oral CapsuleSCD29b91992-c853-a57d-e063-6394a90ab3651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
65862-761-49658620761494000 CAPSULE in 1 BAG (65862-761-49)4000 capsule29-MAR-23Current