Gabapentin

Product NDC
71093-122
11-digit product format
710930122
Labeler code
71093
Product ID
71093-122_e7f50ca2-8338-4d08-b0a7-341624afe79c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71093-122DDiscontinued by firm2026-10-02
excluded packagepackage71093-12271093-122-04DDiscontinued by firm2026-10-02
excluded packagepackage71093-12271093-122-05DDiscontinued by firm2026-10-02

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
A206943-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2018-05-14
A206943-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2018-05-14
A206943-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2018-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206943-001AB
A206943-002AB
A206943-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-09-14 22:38:342026-08A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-09-14 22:38:342026-08A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-14301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206943-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206943-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206943-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A206943-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206943-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206943-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206943-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206943-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206943-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206943-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206943-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206943-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206943-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206943-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206943-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206943-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206943-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206943-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206943-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

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
71093-122-04Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1009
71093-122-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-122-04EA - Each71093-12299bf28e1-32f4-4ae5-9f0f-e3a9a033ecf612018-08-13
71093-122-05EA - Each71093-1224e4a6c19-d467-46a0-b2ee-18910b52683d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-122GABAPENTIN CAPSULE [ACI HEALTHCARE USA, INC.]9Legacy NDC, 2 package rows20231218_7538e255-95df-4991-aae0-a90d709f1e95.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 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINREMEDYREPACK INC.3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef2026-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINREMEDYREPACK INC.4615aaa7-73d4-4473-8f26-e7a982f8a1662026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy57492b91-1fe2-74ab-e063-6394a90a0b9e2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy3c585b71-5cfc-18d6-e063-6294a90a3dcf2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy4ddcdff5-8f1f-bff3-e063-6294a90a11952026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINSt Mary's Medical Park Pharmacyde990f96-96bc-406d-e053-2995a90abebb2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.6ecf5114-2ddc-4025-a36d-1884702dc22a2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.f396ec70-826d-45c6-a27c-343c2fac878c2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINStrides Pharma Science Limited798575b9-ddfa-4915-9574-626abbaf025f2026-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepackca8177ed-1f0d-436e-a5ac-f58b8f7cbb252025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINDirect_Rxf40a4ee4-ae8e-769c-e053-2a95a90a344e2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINADVANCED RX OF TENNESSEE, LLCaf73fbd8-9731-e6bf-e053-2995a90af65d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepackfb0b6613-57d6-4e24-946f-f5f87c460cf02024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepackef37f2a0-3b83-4f71-91c0-6435161b483c2024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.8e6ed5d2-40e0-1f06-e053-2a95a90aa40e2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ed219efc-84e3-5bdc-e053-2a95a90a56fc2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepack38210141-bbdc-4186-b71f-54c72f794dca2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepack75418d32-6504-4cb4-b3a9-afa0eaf19b8d2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNe286ed87-5fbc-4ff2-a05e-1f7fa658bbfc101
310432gabapentin 400 MG Oral CapsuleSCDe286ed87-5fbc-4ff2-a05e-1f7fa658bbfc101
310430gabapentin 100 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310431gabapentin 300 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310432gabapentin 400 MG Oral CapsulePSN7538e255-95df-4991-aae0-a90d709f1e959
310430gabapentin 100 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959
310431gabapentin 300 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959
310432gabapentin 400 MG Oral CapsuleSCD7538e255-95df-4991-aae0-a90d709f1e959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-122-0471093012204100 CAPSULE in 1 BOTTLE, PLASTIC (71093-122-04) 100 capsule2018-08-040000-00-00NoNoCurrent
71093-122-0571093012205500 CAPSULE in 1 BOTTLE, PLASTIC (71093-122-05) 500 capsule2018-08-040000-00-00NoNoCurrent