Gabapentin

Product NDC
68788-7444
Requested package NDC
68788-7444-2
11-digit product format
687887444
Labeler code
68788
Product ID
68788-7444_43038d9a-1f48-49d2-8647-8d3bef7ea237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-744468788-7444-2DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-002GABAPENTIN300MGCAPSULE / ORALAB2018-05-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-003GABAPENTIN400MGCAPSULE / ORALAB2018-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206943-001GABAPENTIN100MGCAPSULE / ORALAB2018-05-141e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206943-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206943-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7444-1EA - Each68788-74443d415951-98b7-4c8c-8d5b-f664d4994d8512020-04-20
68788-7444-2EA - Each68788-7444346d68da-3776-4740-bb0c-2de62739360a12020-04-20
68788-7444-3EA - Each68788-744492b5c865-471d-4f31-bae5-8848c7410ac412020-04-20
68788-7444-4EA - Each68788-7444b2ead829-5822-4bc2-ad23-367e07e75bb212020-04-20
68788-7444-6EA - Each68788-7444f9ca7eca-e721-421d-89eb-1ee1cdf18efb12020-04-20
68788-7444-9EA - Each68788-7444116d139b-bef4-47d9-b863-32f78c55f74212020-04-20

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 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832025-07-30Warnings, 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
GabapentinGABAPENTINBryant Ranch Prepack1ec656c9-034f-4f14-9e6b-9779d41e16272024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943
GabapentinGABAPENTINBryant Ranch Prepack8de89818-805a-4a20-a9b1-48cf443b63152024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7444-26878874440220 CAPSULE in 1 BOTTLE, PLASTIC (68788-7444-2) 20 capsule2019-12-270000-00-00NoNoCurrent