Gabapentin

Product NDC
71335-1348
11-digit product format
713351348
Labeler code
71335
Product ID
71335-1348_d6986373-9217-4068-b8fc-b8afa396f4f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
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 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…

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
1ec656c9-034f-4f14-9e6b-9779d41e1627Available 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1348-0Gabapentin20 in 1 BOTTLECAPSULE204
71335-1348-1Gabapentin30 in 1 BOTTLECAPSULE304
71335-1348-2Gabapentin90 in 1 BOTTLECAPSULE904
71335-1348-3Gabapentin60 in 1 BOTTLECAPSULE604
71335-1348-4Gabapentin120 in 1 BOTTLECAPSULE1204
71335-1348-5Gabapentin100 in 1 BOTTLECAPSULE1004
71335-1348-6Gabapentin28 in 1 BOTTLECAPSULE284
71335-1348-7Gabapentin112 in 1 BOTTLECAPSULE1124
71335-1348-8Gabapentin84 in 1 BOTTLECAPSULE844
71335-1348-9Gabapentin180 in 1 BOTTLECAPSULE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1348-0EA - Each71335-13486b94e59a-322a-4b4c-98d9-3589b8437a8612021-10-08
71335-1348-1EA - Each71335-1348775bd261-57c8-468e-94a0-2c349beb2eaa12019-11-12
71335-1348-2EA - Each71335-1348efdc12c5-7810-4d36-83ae-674ea0b750c512019-11-12
71335-1348-3EA - Each71335-1348c3e06d80-e067-4729-b757-b7d2215ca39612019-11-12
71335-1348-4EA - Each71335-1348d21f7245-50b3-42b3-b371-c7e39cf3e84412021-07-15
71335-1348-5EA - Each71335-1348432ab451-1198-40ee-a57e-784114a991f112021-07-15
71335-1348-9EA - Each71335-1348c8aebcb5-be92-4ce6-95f3-33b5d6fb865312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1348GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20240410_1ec656c9-034f-4f14-9e6b-9779d41e1627.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 · 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
ndc (product): 71335-1348
GabapentinGABAPENTINBryant Ranch Prepack8de89818-805a-4a20-a9b1-48cf443b63152024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206943
application number: ANDA206943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN1ec656c9-034f-4f14-9e6b-9779d41e16274
310431gabapentin 300 MG Oral CapsuleSCD1ec656c9-034f-4f14-9e6b-9779d41e16274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1348-07133513480020 CAPSULE in 1 BOTTLE (71335-1348-0) 20 capsule2020-02-180000-00-00NoNoCurrent
71335-1348-17133513480130 CAPSULE in 1 BOTTLE (71335-1348-1) 30 capsule2019-10-070000-00-00NoNoCurrent
71335-1348-27133513480290 CAPSULE in 1 BOTTLE (71335-1348-2) 90 capsule2019-10-040000-00-00NoNoCurrent
71335-1348-37133513480360 CAPSULE in 1 BOTTLE (71335-1348-3) 60 capsule2019-10-070000-00-00NoNoCurrent
71335-1348-471335134804120 CAPSULE in 1 BOTTLE (71335-1348-4) 120 capsule2019-10-170000-00-00NoNoCurrent
71335-1348-571335134805100 CAPSULE in 1 BOTTLE (71335-1348-5) 100 capsule2020-01-270000-00-00NoNoCurrent
71335-1348-67133513480628 CAPSULE in 1 BOTTLE (71335-1348-6) 28 capsule2024-04-030000-00-00NoNoCurrent
71335-1348-771335134807112 CAPSULE in 1 BOTTLE (71335-1348-7) 112 capsule2024-04-030000-00-00NoNoCurrent
71335-1348-87133513480884 CAPSULE in 1 BOTTLE (71335-1348-8) 84 capsule2024-04-030000-00-00NoNoCurrent
71335-1348-971335134809180 CAPSULE in 1 BOTTLE (71335-1348-9) 180 capsule2019-11-270000-00-00NoNoCurrent