Pregabalin

Product NDC
55700-804
11-digit product format
557000804
Labeler code
55700
Product ID
55700-804_009472ad-3a03-47b2-95d8-faabbb10d86e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-10-11
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-804DDiscontinued by firm2026-08-10
excluded packagepackage55700-80455700-804-30DDiscontinued by firm2026-08-10
excluded packagepackage55700-80455700-804-60DDiscontinued by firm2026-08-10
excluded packagepackage55700-80455700-804-90DDiscontinued by firm2026-08-10

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-804-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-804-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-804-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-804-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-804-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-804-30f5e01cc5f278…a2eaf40c39c3…

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
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 8 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208677-001PREGABALIN25MGCAPSULE / 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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208677-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208677-008AB1b8a1b40f171c…

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
55700-804-30Pregabalin30 in 1 BOTTLECAPSULE3011
55700-804-60Pregabalin60 in 1 BOTTLECAPSULE6011
55700-804-90Pregabalin90 in 1 BOTTLECAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-804-30EA - Each55700-804f5a75f4f-1f7c-407f-8ac4-7e9ca4a8fc7c12019-11-12
55700-804-60EA - Each55700-80497f40c52-a48c-4969-86ac-fd22de5f0e6b12019-11-12
55700-804-90EA - Each55700-80463bb8941-370b-44be-9453-e3693a2a865712019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-804PREGABALIN CAPSULE [QUALITY CARE PRODUCTS, LLC]11Legacy NDC, 3 package rows20241220_c2c53006-de7f-4746-beb1-b9e162b0a5b1.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 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
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-06-04Warnings, 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
PregabalinPREGABALINBryant Ranch Prepackc60f6b1e-7a24-41b2-8435-e20583a732c62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-804-305570008043030 CAPSULE in 1 BOTTLE (55700-804-30) 30 capsule2019-10-110000-00-00NoNoCurrent
55700-804-605570008046060 CAPSULE in 1 BOTTLE (55700-804-60) 60 capsule2019-10-110000-00-00NoNoCurrent
55700-804-905570008049090 CAPSULE in 1 BOTTLE (55700-804-90) 90 capsule2019-10-110000-00-00NoNoCurrent