GABAPENTIN

Product NDC
71335-2521
11-digit product format
713352521
Labeler code
71335
Product ID
71335-2521_9e261ec8-4838-464b-a004-0f9ce246c760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
Substance
GABAPENTIN
Active strength
300 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 44.

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 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10c2088c7a36db…
2026-10-15 13:18:302026-09A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10c2088c7a36db…
2026-10-15 13:18:302026-09A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A214956-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A214956-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A214956-003AB1c2088c7a36db…
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…

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
GABAPENTIN300 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2521-0GABAPENTIN20 in 1 BOTTLECAPSULE202
71335-2521-1GABAPENTIN30 in 1 BOTTLECAPSULE302
71335-2521-2GABAPENTIN90 in 1 BOTTLECAPSULE902
71335-2521-3GABAPENTIN60 in 1 BOTTLECAPSULE602
71335-2521-4GABAPENTIN120 in 1 BOTTLECAPSULE1202
71335-2521-5GABAPENTIN100 in 1 BOTTLECAPSULE1002
71335-2521-6GABAPENTIN28 in 1 BOTTLECAPSULE282
71335-2521-7GABAPENTIN112 in 1 BOTTLECAPSULE1122
71335-2521-8GABAPENTIN84 in 1 BOTTLECAPSULE842
71335-2521-9GABAPENTIN180 in 1 BOTTLECAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2521-2EA - Each71335-2521cf7769aa-741c-4adf-8008-7c4e78c75d0c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2521GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250223_35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01.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
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
ndc (product): 71335-2521
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
310431gabapentin 300 MG Oral CapsulePSN35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012
310431gabapentin 300 MG Oral CapsuleSCD35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2521-07133525210020 CAPSULE in 1 BOTTLE (71335-2521-0) 20 capsule2024-11-04NoNoCurrent
71335-2521-17133525210130 CAPSULE in 1 BOTTLE (71335-2521-1) 30 capsule2024-11-04NoNoCurrent
71335-2521-27133525210290 CAPSULE in 1 BOTTLE (71335-2521-2) 90 capsule2024-11-04NoNoCurrent
71335-2521-37133525210360 CAPSULE in 1 BOTTLE (71335-2521-3) 60 capsule2024-11-04NoNoCurrent
71335-2521-471335252104120 CAPSULE in 1 BOTTLE (71335-2521-4) 120 capsule2024-11-04NoNoCurrent
71335-2521-571335252105100 CAPSULE in 1 BOTTLE (71335-2521-5) 100 capsule2024-11-04NoNoCurrent
71335-2521-67133525210628 CAPSULE in 1 BOTTLE (71335-2521-6) 28 capsule2024-11-04NoNoCurrent
71335-2521-771335252107112 CAPSULE in 1 BOTTLE (71335-2521-7) 112 capsule2024-11-04NoNoCurrent
71335-2521-87133525210884 CAPSULE in 1 BOTTLE (71335-2521-8) 84 capsule2024-11-04NoNoCurrent
71335-2521-971335252109180 CAPSULE in 1 BOTTLE (71335-2521-9) 180 capsule2024-11-04NoNoCurrent