Gabapentin

Product NDC
71205-295
Requested package NDC
71205-295-60
11-digit product format
712050295
Labeler code
71205
Product ID
71205-295_9e09d2f6-13f0-4e5e-aea2-e212ade2fcfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078787-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2008-01-31
A078787-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2008-01-31
A078787-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078787-001AB
A078787-002AB
A078787-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-002GABAPENTIN300MGCAPSULE / ORALAB2008-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-003GABAPENTIN400MGCAPSULE / ORALAB2008-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078787-001GABAPENTIN100MGCAPSULE / ORALAB2008-01-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078787-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078787-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078787-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078787-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078787-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078787-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078787-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078787-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078787-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078787-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078787-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078787-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078787-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078787-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078787-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078787-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078787-001AB18072bd15b7f6…

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
ded42b88-94dd-462d-bcdf-7fd34d1e49c3Available 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
71205-295-15Gabapentin15 in 1 BOTTLECAPSULE155
71205-295-30Gabapentin30 in 1 BOTTLECAPSULE305
71205-295-60Gabapentin60 in 1 BOTTLECAPSULE605
71205-295-90Gabapentin90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-295-15EA - Each71205-295b1c98c03-3f24-4333-a9b3-a75717edb95212019-11-12
71205-295-30EA - Each71205-2956eea9efb-69b6-4c21-8564-5bd687f0d80f12019-11-12
71205-295-60EA - Each71205-295b072141f-06ce-41c8-b351-f941cf7168d312019-10-07
71205-295-90EA - Each71205-295bb157cdb-733c-4178-bcc0-6cf16e3b023712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-295GABAPENTIN CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20200818_ded42b88-94dd-462d-bcdf-7fd34d1e49c3.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.6beed8eb-446c-4575-8dc8-b798623d92c72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepack912d8697-b466-48dc-88d3-d2ba90e766442026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutions3dbd447f-4791-4c62-86b4-6f79288627852026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutions67330eef-c976-4862-b1ae-20f30f43df762026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackefb86e22-5a84-4b33-aad0-71dd5a2c6c8f2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackeaf5e41e-8ed3-404e-84e0-392bebdbc0b72025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepack344d67fa-092e-4e71-b96a-25c71bfa6bb12025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackbc1316b6-1fc4-4990-95a8-4898817728762025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINNorthStar Rx LLCf7c1fd34-d615-43a2-8989-898fe11f90df2025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutionsd25daaac-a8ab-4f12-acc2-4ec8fc97a2d42025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAurobindo Pharma Limited1a619a14-0b63-4cba-80e7-474c9a1c90b92025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb33c18ea-554d-3cfb-e053-2a95a90a2dd12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCbc08e35d-ef5d-1dcd-e053-2a95a90ab5de2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBryant Ranch Prepackff28c5f1-da56-4072-a6fa-d689d4a6761b2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINBoswell Pharmacy Services LLC d/b/a BPS Wholesale1e28ad3d-2d34-a5d0-e063-6294a90adb9e2024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINA-S Medication Solutionsecb798a0-377d-4712-bb82-ec9d7116962f2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC3b4395f2-9440-4b67-97cc-5d16f3bdd05e2020-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINProficient Rx LPded42b88-94dd-462d-bcdf-7fd34d1e49c32020-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
ndc (package): 71205-295-60
ndc (product): 71205-295
ndc11 (package): 71205029560
GabapentinGABAPENTINProficient Rx LP7d77dae0-df76-4b7b-9690-713e9a60e3cd2019-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC5fbd601f-df95-4a79-a7d3-c3505e23b9132018-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078787
application number: ANDA078787

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNded42b88-94dd-462d-bcdf-7fd34d1e49c35
310431gabapentin 300 MG Oral CapsuleSCDded42b88-94dd-462d-bcdf-7fd34d1e49c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-295-607120502956060 CAPSULE in 1 BOTTLE (71205-295-60) 60 capsule2019-07-010000-00-00NoNoCurrent