Gabapentin

Product NDC
45865-216
11-digit product format
458650216
Labeler code
45865
Product ID
45865-216_1277f18a-a854-3b06-e063-6294a90a88b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 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
310430Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1278512b-1493-db65-e063-6394a90ab161Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-216-30Gabapentin30 in 1 BOTTLECAPSULE301
45865-216-51Gabapentin120 in 1 BOTTLECAPSULE1201
45865-216-60Gabapentin60 in 1 BOTTLECAPSULE601
45865-216-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-216GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1Current NDC, 4 package rows20240301_1278512b-1493-db65-e063-6394a90ab161.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
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
310430gabapentin 100 MG Oral CapsulePSN1278512b-1493-db65-e063-6394a90ab1611
310430gabapentin 100 MG Oral CapsuleSCD1278512b-1493-db65-e063-6394a90ab1611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45865-216-304586502163030 CAPSULE in 1 BOTTLE (45865-216-30) 30 capsule2022-09-15NoNoCurrent
45865-216-5145865021651120 CAPSULE in 1 BOTTLE (45865-216-51) 120 capsule2022-06-02NoNoCurrent
45865-216-604586502166060 CAPSULE in 1 BOTTLE (45865-216-60) 60 capsule2024-02-23NoNoCurrent
45865-216-904586502169090 CAPSULE in 1 BOTTLE (45865-216-90) 90 capsule2022-06-13NoNoCurrent