Pregabalin

Product NDC
71335-1745
Requested package NDC
71335-1745-2
11-digit product format
713351745
Labeler code
71335
Product ID
71335-1745_db23090f-cc98-4f5c-9a82-32ad5bb106bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
Substance
PREGABALIN
Active strength
150 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-174571335-1745-2IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A207799-001PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A207799-002PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A207799-003PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A207799-004PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A207799-005PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A207799-006PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-07-19
A207799-007PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-09-30
A207799-008PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207799-001AB
A207799-002AB
A207799-003AB
A207799-004AB
A207799-005AB
A207799-006AB
A207799-007AB
A207799-008AB

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 · 324 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-306a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207799-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A207799-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A207799-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207799-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207799-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207799-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207799-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207799-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207799-008AB16a471c1ec25d…

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
PREGABALIN150 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08ad87e3-e00c-46d1-98f8-df493cf1712eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1745-12024-04-08These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-22024-04-08These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-32024-04-08These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-42024-04-08These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-12024-01-30These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-22024-01-30These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-32024-01-30These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1745-42024-01-30These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1745-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1745-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1745-3Pregabalin90 in 1 BOTTLECAPSULE90104
71335-1745-4Pregabalin180 in 1 BOTTLECAPSULE180104
71335-1745-5Pregabalin120 in 1 BOTTLECAPSULE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1745-1EA - Each71335-1745b02f954e-9f20-45c0-a0c9-46a9b0bbce9e12021-07-15
71335-1745-2EA - Each71335-1745c73ac0ce-e7f1-4a97-bca3-da898eb666db12021-07-15
71335-1745-3EA - Each71335-1745b915122a-0dfd-4aef-961d-029d49d9d31612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1745PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240915_08ad87e3-e00c-46d1-98f8-df493cf1712e.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d3486c-c6ea-4d31-e063-6294a90a12192026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d387dd-bc7f-37a4-e063-6394a90abbbb2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINClinical Solutions Wholesale, LLC150c8b71-98b0-4c6b-b20f-fd0fca2d3c262026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY3dd7930b-f544-f18b-e063-6294a90a05412026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINClinical Solutions Wholesale, LLC613a7a13-d5ba-4827-91ec-3ed5176602b72026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepackb5b22ec1-3fd8-4631-ba7e-98d8e5d030b32025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINPreferred Pharmaceuticals Inc.e8e272a4-c181-4573-822b-2bb315b6ad372025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINPreferred Pharmaceuticals Inc.a0da0534-b386-4c93-ae89-03b0e3325e022025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc89a3514-f637-e54f-e053-2a95a90a68812024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PREGABALINPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd2813712-d7f6-6144-e053-2995a90a3c5d2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepack4cda70e8-9ae1-4958-8c86-1bc633be982b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepackcf7f0fd0-bac2-4836-9363-79d32ad0cc102024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINBryant Ranch Prepack08ad87e3-e00c-46d1-98f8-df493cf1712e2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (package): 71335-1745-2
ndc (product): 71335-1745
ndc11 (package): 71335174502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN08ad87e3-e00c-46d1-98f8-df493cf1712e104
483440pregabalin 150 MG Oral CapsuleSCD08ad87e3-e00c-46d1-98f8-df493cf1712e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1745-27133517450260 CAPSULE in 1 BOTTLE (71335-1745-2) 60 capsule2020-12-300000-00-00NoNoCurrent