Pregabalin

Product NDC
69238-1317
11-digit product format
692381317
Labeler code
69238
Product ID
69238-1317_670cafeb-c249-4782-838c-9537d3ede28b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209743
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
300 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 42.

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
A209743-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A209743-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A209743-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A209743-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A209743-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A209743-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A209743-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A209743-008PREGABALINPREGABALIN300MGCAPSULE / 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
A209743-001AB
A209743-002AB
A209743-003AB
A209743-004AB
A209743-005AB
A209743-006AB
A209743-007AB
A209743-008AB

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 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209743-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008AB1fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN300 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
3d9d7123-5886-4b61-a7ea-471b213e77d9Available 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
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1317-5Pregabalin500 in 1 BOTTLECAPSULE5008
69238-1317-9Pregabalin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1317-9EA - Each69238-1317bde32628-4121-4cee-93c1-1760616097fe12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1317PREGABALIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 2 package rows20240807_3d9d7123-5886-4b61-a7ea-471b213e77d9.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
ndc (product): 69238-1317
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3099759f-cb24-40e8-b482-9388c38c73b92025-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINProficient Rx LPa17f03ea-9375-48fe-be32-f8df509f5fba2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483440pregabalin 150 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483446pregabalin 200 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
577127pregabalin 225 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483442pregabalin 25 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483444pregabalin 300 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483448pregabalin 50 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483450pregabalin 75 MG Oral CapsulePSN3d9d7123-5886-4b61-a7ea-471b213e77d98
483438pregabalin 100 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483440pregabalin 150 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483446pregabalin 200 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
577127pregabalin 225 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483442pregabalin 25 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483444pregabalin 300 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483448pregabalin 50 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483450pregabalin 75 MG Oral CapsuleSCD3d9d7123-5886-4b61-a7ea-471b213e77d98
483444pregabalin 300 MG Oral CapsulePSNbc1b143d-feaf-9498-e053-2995a90acf505
483444pregabalin 300 MG Oral CapsuleSCDbc1b143d-feaf-9498-e053-2995a90acf505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1317-569238131705500 CAPSULE in 1 BOTTLE (69238-1317-5) 500 capsule2019-07-19NoNoCurrent
69238-1317-96923813170990 CAPSULE in 1 BOTTLE (69238-1317-9) 90 capsule2019-07-190000-00-00NoNoCurrent