GABAPENTIN

Product NDC
31722-149
11-digit product format
317220149
Labeler code
31722
Product ID
31722-149_2a2c08de-b06c-4926-e063-6394a90a2eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
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 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
A214956-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2021-05-10
A214956-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2021-05-10
A214956-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2021-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214956-001AB
A214956-002AB
A214956-003AB

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 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-002GABAPENTIN300MGCAPSULE / ORALAB2021-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-003GABAPENTIN400MGCAPSULE / ORALAB2021-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214956-001GABAPENTIN100MGCAPSULE / ORALAB2021-05-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214956-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214956-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214956-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214956-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214956-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214956-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214956-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214956-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214956-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214956-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214956-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214956-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214956-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214956-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214956-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214956-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214956-001AB18072bd15b7f6…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8a30eb7-3fc5-456a-bdae-3f4095bf2c2bAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-149-01GABAPENTIN100 in 1 BOTTLECAPSULE1003
31722-149-05GABAPENTIN500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-149-01EA - Each31722-14953a40232-31e1-4173-bf0f-4f08e0c9324f12021-12-08
31722-149-05EA - Each31722-1492a76849d-ae0a-403d-8534-a3d53f55abef12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-149GABAPENTIN (GABAPENTIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241228_e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy235a6954-318a-9e3a-e063-6394a90a0e212026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.dd0e12c2-1986-4ca3-a809-d703a75424192026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions4aa69d04-6b32-4764-a48b-ef5313dd95d32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions43a3ec78-8235-4d46-a343-2f9226745a392026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions685553b0-384e-400b-a8ae-612ceece82612026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINA-S Medication Solutions7ea0b220-edbb-45eb-aeb3-65283f8489a12026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINNorthwind Health Company, LLC47214c7c-ba1b-9107-e063-6294a90a54312025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINRedpharm Drug44f2b497-55b2-864f-e063-6294a90ad6d52025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINREMEDYREPACK INC.fbeccab7-08aa-4da3-868f-b47a1f3d41ef2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.618c948d-deee-44e2-98f0-e5232171dd502025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.200b61d7-6e4c-923d-e063-6294a90a42cf2025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINBryant Ranch Prepack35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.2b395a14-0f8e-7f5b-e063-6294a90ab5462025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
ndc (product): 31722-149
GABAPENTINGABAPENTINAsclemed USA, Inc.17a62334-209d-4dc1-867a-e5780196a2ca2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCf38098ec-dd1a-405a-bbfb-bad62e4e7fa52024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214956
application number: ANDA214956

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsulePSN43a3ec78-8235-4d46-a343-2f9226745a393
310431gabapentin 300 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsulePSN4aa69d04-6b32-4764-a48b-ef5313dd95d33
310432gabapentin 400 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310430gabapentin 100 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsuleSCD43a3ec78-8235-4d46-a343-2f9226745a393
310431gabapentin 300 MG Oral CapsuleSCD4aa69d04-6b32-4764-a48b-ef5313dd95d33
310431gabapentin 300 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310432gabapentin 400 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsulePSN35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012
310431gabapentin 300 MG Oral CapsuleSCD35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012
310430gabapentin 100 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310431gabapentin 300 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310432gabapentin 400 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310430gabapentin 100 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1
310431gabapentin 300 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1
310432gabapentin 400 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-149-0131722014901100 CAPSULE in 1 BOTTLE (31722-149-01) 100 capsule2021-05-100000-00-00NoNoCurrent
31722-149-0531722014905500 CAPSULE in 1 BOTTLE (31722-149-05) 500 capsule2021-05-100000-00-00NoNoCurrent