Gabapentin

Product NDC
55700-950
11-digit product format
557000950
Labeler code
55700
Product ID
55700-950_a1d85d35-87be-497d-acf2-5f9ef9267328
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2021-12-16
Marketing end
2027-02-28
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-95055700-950-01DDiscontinued by firm2026-08-11
excluded packagepackage55700-95055700-950-90DDiscontinued by firm2026-08-11

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-95055700-950-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-95055700-950-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204989-001RELGAABIGABAPENTIN100MGCAPSULE / ORALAB2016-02-18
A204989-002RELGAABIGABAPENTIN300MGCAPSULE / ORALAB2016-02-18
A204989-003RELGAABIGABAPENTIN400MGCAPSULE / ORALAB2016-02-18
A204989-004RELGAABIGABAPENTIN200MGCAPSULE / ORALAB2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204989-001AB
A204989-002AB
A204989-003AB
A204989-004AB

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 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204989-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204989-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204989-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204989-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed3a0d48-2e98-44ee-8743-880d1221a480Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-950-01Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1206
55700-950-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE306
55700-950-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE606
55700-950-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-950-01EA - Each55700-950639dcc37-dc74-4501-bc37-5a1bed7facc612022-03-09
55700-950-30EA - Each55700-9503656f8dd-d710-4623-849b-08e07481e17012022-03-09
55700-950-60EA - Each55700-9500bd1617f-0cf0-4efe-95bb-c5c86b71569112022-03-09
55700-950-90EA - Each55700-950f8c4f0a3-7fc8-450d-944f-149a0237992412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-950GABAPENTIN CAPSULE [QUALITY CARE PRODUCTS, LLC]6Current NDC, Legacy NDC, 4 package rows20241220_ed3a0d48-2e98-44ee-8743-880d1221a480.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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.e877a425-2b7f-4e43-a1f9-24019cbf96852026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.16542ee6-0e0e-4d3c-8b32-60ff6ef488462026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINHAWAII REPACK, INC.dd7adad2-e2f5-4b43-90a4-522bce0be5b32026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINNorthwind Health Company, LLC1b44a3ab-4d06-205f-e063-6294a90af3682026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINAsclemed USA, Inc.9a829dc3-b2d8-4d19-a579-0597217cec9b2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb7a29b99-ce23-950e-e053-2995a90a19342026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack4c49d34d-bb47-406b-8f2d-b4834b2ee9d02026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINCoupler LLC5385e27c-f2fa-32d5-e063-6294a90a0a8c2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb8b7e045-a7fe-8539-e053-2a95a90a40f82026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.100ff86c-56a8-4770-9db3-b9bc6b1bd2f72026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.e3429322-c442-4146-bb68-bcc3a8d015522026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.2625c0ef-5295-41de-9e81-88001a6cbecc2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.41dcc917-68d1-49f0-8223-44c21ca259ef2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINCoupler LLC5073abda-321f-29d1-e063-6394a90a59ac2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPHOENIX RX LLC4f95c01f-200e-bfd7-e063-6394a90abc382026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsulePSNed3a0d48-2e98-44ee-8743-880d1221a4806
310430gabapentin 100 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806
310431gabapentin 300 MG Oral CapsuleSCDed3a0d48-2e98-44ee-8743-880d1221a4806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-950-0155700095001120 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-01) 120 capsule2022-01-040000-00-00NoNoCurrent
55700-950-305570009503030 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-30) 30 capsule2021-12-162027-02-28NoNoCurrent
55700-950-605570009506060 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-60) 60 capsule2021-12-162027-02-28NoNoCurrent
55700-950-905570009509090 CAPSULE in 1 BOTTLE, PLASTIC (55700-950-90) 90 capsule2021-12-170000-00-00NoNoCurrent