FDA.reportPublic FDA data

Gabapentin

Product NDC
72888-104
11-digit product format
728880104
Labeler code
72888
Product ID
72888-104_4b921bb1-ab2e-af6a-e063-6294a90a0694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216492
Marketing category
ANDA
Marketing start
2023-01-18
Substance
GABAPENTIN
Active strength
250 mg/5mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216492-001GABAPENTINGABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216492-001AA

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
2026-09-14 22:38:342026-08A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-1884e616aacf4f…
2026-08-18 06:07:402026-07A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216492-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2023-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216492-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A216492-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216492-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216492-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216492-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216492-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216492-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216492-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216492-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216492-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216492-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216492-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216492-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216492-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216492-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216492-001AA18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216492-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216492-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216492-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216492-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216492-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216492-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216492-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216492-001AA1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216492-001AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN250 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283523Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfee67dc-d2b1-4a00-92d9-a42be3189c74Available 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
72888-104-25Gabapentin470 mL in 1 BOTTLESOLUTION4704

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-104-25ML - Milliliter72888-10444c49938-8cc3-4342-bf56-c368405afb4c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-104GABAPENTIN SOLUTION [ADVAGEN PHARMA LTD]2Current NDC, 1 package rows20231225_bfee67dc-d2b1-4a00-92d9-a42be3189c74.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvagen Pharma Ltdbfee67dc-d2b1-4a00-92d9-a42be3189c742026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216492
application number: ANDA216492
ndc (product): 72888-104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSNbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 50 MG/ML Oral SolutionSCDbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 250 MG per 5 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 300 MG per 6 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 500 MG per 10 ML Oral SolutionSYbfee67dc-d2b1-4a00-92d9-a42be3189c744
283523gabapentin 250 MG in 5 mL Oral SolutionPSN1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 50 MG/ML Oral SolutionSCD1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 250 MG per 5 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 300 MG per 6 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1
283523gabapentin 500 MG per 10 ML Oral SolutionSY1ec2e07e-5a8e-41e5-9ece-485431c7c4ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-104-2572888010425470 mL in 1 BOTTLE (72888-104-25) 470 ml2023-06-12NoNoCurrent