Pregabalin

Product NDC
60505-3797
11-digit product format
605053797
Labeler code
60505
Product ID
60505-3797_aa1fe661-3f3b-f456-f1ce-6212f5267042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
ApotexCorp
Application
ANDA211685
Marketing category
ANDA
Marketing start
2022-06-20
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
150 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-3797DDiscontinued by firm2026-10-16
excluded packagepackage60505-379760505-3797-9DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-3797-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-3797-9f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211685-001PREGABALINPREGABALIN25MGCAPSULE / ORAL2021-07-07
A211685-002PREGABALINPREGABALIN50MGCAPSULE / ORAL2021-07-07
A211685-003PREGABALINPREGABALIN75MGCAPSULE / ORAL2021-07-07
A211685-004PREGABALINPREGABALIN100MGCAPSULE / ORAL2021-07-07
A211685-005PREGABALINPREGABALIN150MGCAPSULE / ORAL2021-07-07
A211685-006PREGABALINPREGABALIN200MGCAPSULE / ORAL2021-07-07
A211685-007PREGABALINPREGABALIN225MGCAPSULE / ORAL2021-07-07
A211685-008PREGABALINPREGABALIN300MGCAPSULE / ORAL2021-07-07

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 8 · 288 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A211685-001PREGABALIN25MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-002PREGABALIN50MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-003PREGABALIN75MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-004PREGABALIN100MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-005PREGABALIN150MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-006PREGABALIN200MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-007PREGABALIN225MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-10-15 13:18:302026-09A211685-008PREGABALIN300MGCAPSULE / ORAL2021-07-07c2088c7a36db…
2026-09-14 22:38:342026-08A211685-001PREGABALIN25MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-002PREGABALIN50MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-003PREGABALIN75MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-004PREGABALIN100MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-005PREGABALIN150MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-006PREGABALIN200MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-007PREGABALIN225MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A211685-008PREGABALIN300MGCAPSULE / ORAL2021-07-0784e616aacf4f…
2026-08-18 06:07:402026-07A211685-001PREGABALIN25MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-002PREGABALIN50MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-003PREGABALIN75MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-004PREGABALIN100MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-005PREGABALIN150MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-006PREGABALIN200MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-007PREGABALIN225MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211685-008PREGABALIN300MGCAPSULE / ORAL2021-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211685-001PREGABALIN25MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-002PREGABALIN50MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-003PREGABALIN75MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-004PREGABALIN100MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-005PREGABALIN150MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-006PREGABALIN200MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-007PREGABALIN225MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211685-008PREGABALIN300MGCAPSULE / ORAL2021-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-001PREGABALIN25MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-002PREGABALIN50MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-003PREGABALIN75MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-004PREGABALIN100MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-005PREGABALIN150MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-006PREGABALIN200MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-007PREGABALIN225MGCAPSULE / ORAL2021-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211685-008PREGABALIN300MGCAPSULE / ORAL2021-07-0731067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 232 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-005AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-006AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-007AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211685-008AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211685-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-005AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-006AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-007AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211685-008AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-006AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-007AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211685-008AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-006AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-007AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211685-008AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-006AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-007AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211685-008AB11e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3797-9EA - Each60505-379789525d9d-fd05-42d6-bb97-cdb64882121e12022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3797-96050537970990 CAPSULE in 1 BOTTLE (60505-3797-9) 90 capsule2022-06-200000-00-00NoNoCurrent