FDA.reportPublic FDA data

Gabapentin

Product NDC
43547-481
11-digit product format
435470481
Labeler code
43547
Product ID
43547-481_360d953b-4313-45ae-b933-296547d4577d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA219814
Marketing category
ANDA
Marketing start
2026-04-29
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A219814-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2026-03-06
A219814-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2026-03-06
A219814-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2026-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219814-001AB
A219814-002AB
A219814-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-001GABAPENTIN100MGCAPSULE / ORALAB2026-03-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-002GABAPENTIN300MGCAPSULE / ORALAB2026-03-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-003GABAPENTIN400MGCAPSULE / ORALAB2026-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219814-003AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 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
360d953b-4313-45ae-b933-296547d4577dAvailable 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
43547-481-10Gabapentin100 in 1 BOTTLECAPSULE1001
43547-481-50Gabapentin500 in 1 BOTTLECAPSULE5001

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINSolco Healthcare US, LLC360d953b-4313-45ae-b933-296547d4577d2026-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219814
application number: ANDA219814
ndc (product): 43547-481

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310431gabapentin 300 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310432gabapentin 400 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310430gabapentin 100 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1
310431gabapentin 300 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1
310432gabapentin 400 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-481-1043547048110100 CAPSULE in 1 BOTTLE (43547-481-10) 100 capsule2026-04-29NoNoCurrent
43547-481-5043547048150500 CAPSULE in 1 BOTTLE (43547-481-50) 500 capsule2026-04-29NoNoCurrent