GABAPENTIN

Product NDC
72865-252
Requested package NDC
72865-252-05
11-digit product format
728650252
Labeler code
72865
Product ID
72865-252_702f8307-681f-440d-9f1d-3d26141a914b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
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 43.

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
A214956-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2021-05-10
A214956-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2021-05-10
A214956-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2021-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214956-001AB
A214956-002AB
A214956-003AB

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 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1084e616aacf4f…
2026-09-14 22:38:342026-08A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1084e616aacf4f…
2026-09-14 22:38:342026-08A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1084e616aacf4f…
2026-08-18 06:07:402026-07A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214956-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214956-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214956-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A214956-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214956-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214956-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214956-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214956-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214956-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-001AB1301d65b070ca…

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
2026-12-31

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
618c948d-deee-44e2-98f0-e5232171dd50Available 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
72865-252-05GABAPENTIN500 in 1 BOTTLECAPSULE5003
72865-252-18GABAPENTIN180 in 1 BOTTLECAPSULE1803
72865-252-27GABAPENTIN270 in 1 BOTTLECAPSULE2703
72865-252-90GABAPENTIN90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-252-05EA - Each72865-252373b63b1-1141-4e41-82c8-f9eb77d3555912023-12-05
72865-252-18EA - Each72865-25288961d90-80ae-4f7c-886e-de2bbabb11b812023-12-05
72865-252-27EA - Each72865-25216459db2-738c-4a97-97fa-bb0aa02d328012023-12-05
72865-252-90EA - Each72865-25274ed2884-da59-40ea-a8ea-560aba0fdfdb12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-252GABAPENTIN CAPSULE [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20231122_618c948d-deee-44e2-98f0-e5232171dd50.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy235a6954-318a-9e3a-e063-6394a90a0e212026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.dd0e12c2-1986-4ca3-a809-d703a75424192026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions4aa69d04-6b32-4764-a48b-ef5313dd95d32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions43a3ec78-8235-4d46-a343-2f9226745a392026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions685553b0-384e-400b-a8ae-612ceece82612026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions7ea0b220-edbb-45eb-aeb3-65283f8489a12026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINNorthwind Health Company, LLC47214c7c-ba1b-9107-e063-6294a90a54312025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINRedpharm Drug44f2b497-55b2-864f-e063-6294a90ad6d52025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.618c948d-deee-44e2-98f0-e5232171dd502025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
ndc (package): 72865-252-05
ndc (product): 72865-252
ndc11 (package): 72865025205
GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.200b61d7-6e4c-923d-e063-6294a90a42cf2025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINBryant Ranch Prepack35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.2b395a14-0f8e-7f5b-e063-6294a90ab5462025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINAsclemed USA, Inc.17a62334-209d-4dc1-867a-e5780196a2ca2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCf38098ec-dd1a-405a-bbfb-bad62e4e7fa52024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310431gabapentin 300 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310432gabapentin 400 MG Oral CapsulePSNf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310430gabapentin 100 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310431gabapentin 300 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310432gabapentin 400 MG Oral CapsuleSCDf38098ec-dd1a-405a-bbfb-bad62e4e7fa56
310430gabapentin 100 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310431gabapentin 300 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310432gabapentin 400 MG Oral CapsulePSN618c948d-deee-44e2-98f0-e5232171dd503
310430gabapentin 100 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503
310431gabapentin 300 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503
310432gabapentin 400 MG Oral CapsuleSCD618c948d-deee-44e2-98f0-e5232171dd503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-252-0572865025205500 CAPSULE in 1 BOTTLE (72865-252-05) 500 capsule2021-05-10NoNoCurrent