Pregabalin

Product NDC
70518-3636
11-digit product format
705183636
Labeler code
70518
Product ID
70518-3636_4f6d2acc-e030-4938-e063-6394a90a355d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207799
Marketing category
ANDA
Marketing start
2023-02-09
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 8 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-001PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-002PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-003PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-004PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-005PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-006PREGABALIN300MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-007PREGABALIN25MGCAPSULE / ORALAB2019-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-008PREGABALIN50MGCAPSULE / ORALAB2019-09-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207799-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207799-008AB1b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN50 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
483448Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47d08b8f-a24d-4159-ab43-2eb67a93559bAvailable 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
70518-3636-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3636-1Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608
70518-3636-2Pregabalin120 in 1 BOTTLE, PLASTICCAPSULE1208
70518-3636-3Pregabalin30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3636-0EA - Each70518-363635070807-a55b-4059-9937-6c232a72605312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3636PREGABALIN CAPSULE [REMEDYREPACK INC.]4Current NDC, 4 package rows20241012_47d08b8f-a24d-4159-ab43-2eb67a93559b.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
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
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
ndc (product): 70518-3636
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207799
application number: ANDA207799
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-04-13Warnings, 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
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2025-09-17Warnings, 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
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2025-08-11Warnings, 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN47d08b8f-a24d-4159-ab43-2eb67a93559b8
483448pregabalin 50 MG Oral CapsuleSCD47d08b8f-a24d-4159-ab43-2eb67a93559b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3636-07051836360090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3636-0) 90 capsule2023-02-09NoNoCurrent
70518-3636-17051836360160 CAPSULE in 1 BOTTLE, PLASTIC (70518-3636-1) 60 capsule2023-05-18NoNoCurrent
70518-3636-270518363602120 CAPSULE in 1 BOTTLE, PLASTIC (70518-3636-2) 120 capsule2025-06-16NoNoCurrent
70518-3636-37051836360330 CAPSULE in 1 BOTTLE, PLASTIC (70518-3636-3) 30 capsule2025-09-17NoNoCurrent