Gabapentin

Product NDC
50090-3200
11-digit product format
500903200
Labeler code
50090
Product ID
50090-3200_96a7580e-bd98-4869-9981-097278189351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090858-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2010-12-17
A090858-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2010-12-17
A090858-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090858-001AB
A090858-002AB
A090858-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001AB18072bd15b7f6…

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03031adf-d36b-45ec-944e-dfce5a5de91aAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3200-0Gabapentin30 in 1 BOTTLECAPSULE3044
50090-3200-1Gabapentin100 in 1 BOTTLECAPSULE10044
50090-3200-2Gabapentin90 in 1 BOTTLECAPSULE9044
50090-3200-3Gabapentin42 in 1 BOTTLECAPSULE4244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3200-0EA - Each50090-3200bbe999d9-7969-4ac6-bd91-11c1d34b313b12019-05-02
50090-3200-1EA - Each50090-3200847c38ec-7187-4631-abd8-c7a2b57cf89912019-05-02
50090-3200-2EA - Each50090-320076686177-1bfa-4138-b1ce-d439b703893312019-05-02
50090-3200-3EA - Each50090-3200b248f2c5-4fbc-44d2-8756-a84f629b001412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3200GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]40Current NDC, Legacy NDC, 4 package rows20250417_03031adf-d36b-45ec-944e-dfce5a5de91a.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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepacka1006139-7dfc-4d87-a5a9-aeb380c32d242026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.896c7782-1137-454b-aaa6-28f42c7413ef2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepack6a0a75ac-e121-477b-a9d1-d11f588afc9d2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals36f74fdf-0dae-47a0-a7ea-e64ac91cd88f2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINHAWAII REPACK, INC.14d61caa-17ce-4fa2-90fb-1470f3864be82026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC552912b2-be59-0333-e063-6394a90a85c02026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC55292235-bf8f-46d0-e063-6294a90a91a52026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.3e633cd0-5ee8-4a05-bcfc-0a80209bf27f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINUnit Dose Solutions, Inc.54ecc64b-f019-9fcb-e063-6294a90a00af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINCardinal Health 107, LLC41844c21-9e2a-4332-a8ff-9b71ae9032b02026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 50090-3200
GabapentinGABAPENTINCardinal Health 107, LLCd4f21e97-5e55-44c9-9b31-5f79ac2eb5122026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310430gabapentin 100 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3200-05009032000030 CAPSULE in 1 BOTTLE (50090-3200-0) 30 capsule2018-01-170000-00-00NoNoCurrent
50090-3200-150090320001100 CAPSULE in 1 BOTTLE (50090-3200-1) 100 capsule2018-01-050000-00-00NoNoCurrent
50090-3200-25009032000290 CAPSULE in 1 BOTTLE (50090-3200-2) 90 capsule2017-10-230000-00-00NoNoCurrent
50090-3200-35009032000342 CAPSULE in 1 BOTTLE (50090-3200-3) 42 capsule2024-05-14NoNoCurrent