GABAPENTIN

Product NDC
71610-630
Requested package NDC
71610-630-60
11-digit product format
716100630
Labeler code
71610
Product ID
71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
800 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214957-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12021-10-01
A214957-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12021-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214957-001AB1
A214957-002AB1

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-016a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-016a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214957-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214957-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214957-001AB116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214957-002AB116a51e52b5d6a…

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 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
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17988b64-723c-488d-befd-3e4e4cc44bd2Available 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
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
71610-630-30GABAPENTIN30 in 1 BOTTLETABLET303
71610-630-45GABAPENTIN45 in 1 BOTTLETABLET453
71610-630-53GABAPENTIN60 in 1 BOTTLETABLET603
71610-630-60GABAPENTIN90 in 1 BOTTLETABLET903
71610-630-70GABAPENTIN120 in 1 BOTTLETABLET1203
71610-630-73GABAPENTIN135 in 1 BOTTLETABLET1353
71610-630-80GABAPENTIN180 in 1 BOTTLETABLET1803
71610-630-92GABAPENTIN270 in 1 BOTTLETABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-630-30EA - Each71610-630d96382d0-9651-40c4-885f-4299ab52a2f512022-06-06
71610-630-45EA - Each71610-630e652e3e6-b066-47fa-8324-ef4b99adf84312022-06-06
71610-630-53EA - Each71610-6304072e18d-1ccd-444d-8ccd-43205fadf88f12022-06-06
71610-630-60EA - Each71610-63086f15893-04ed-4609-9435-ba2a15e76dcd12022-06-06
71610-630-70EA - Each71610-63033a70604-2aea-4278-98ff-ef25fa444c4a12022-06-06
71610-630-73EA - Each71610-63067500e8f-0cc0-489a-a5f9-8a0e6d05367212022-06-06
71610-630-80EA - Each71610-630ea72251c-1001-4957-b3df-035c584a364812022-04-06
71610-630-92EA - Each71610-63077117e95-d4d3-411a-b06d-abc84e4c798212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-630GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 8 package rows20220512_17988b64-723c-488d-befd-3e4e4cc44bd2.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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINBryant Ranch Prepackc9f0cceb-b24e-4526-b873-fedd877d6bc62026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy07f07d15-ee91-8c2a-e063-6394a90a46242026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC500ee820-0378-6fc9-e063-6394a90a109c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY4ddc1342-5c83-f562-e063-6294a90a29ba2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINBryant Ranch Prepack2e331641-ec26-4d76-b16b-a9863c767afe2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.60b46f6d-efbc-487a-b672-b20df8b44cc42026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.9ead7825-d11b-4e00-8533-328d097b8f832025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.a88edb00-2189-4c8d-9dd7-9fe1571775cc2025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxed9c501c-24e4-da89-e053-2a95a90a64c62025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINAsclemed USA, Inc.1f1203f4-2184-4e13-e063-6394a90a43302025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LP7fcce531-bf7c-43b6-bea9-8f0602842c532025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC3133c863-d33b-c9d7-e063-6294a90ae8982025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.febf610e-e088-4797-e053-6294a90a3eb52025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxfbc05ceb-2e69-3c37-e053-6394a90ac4f42024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINClinical Solutions Wholesale, LLC934fefae-b895-427c-8798-4c5462b1ecc22024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN17988b64-723c-488d-befd-3e4e4cc44bd23
310434gabapentin 800 MG Oral TabletSCD17988b64-723c-488d-befd-3e4e4cc44bd23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-630-607161006306090 TABLET in 1 BOTTLE (71610-630-60) 90 tablet2022-04-200000-00-00NoNoCurrent