PREGABALIN

Product NDC: 72189-033
11-digit product format: 721890033
Labeler code: 72189
Product ID: 72189-033_2be8eb66-533f-0815-e063-6294a90a115d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA209743
Marketing category: ANDA
Marketing start: 2019-09-05
Substance: PREGABALIN
Active strength: 100 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72189-033		I	Inactivated by FDA	2026-09-09
excluded product	product	72189-033		I	Inactivated by FDA	2026-09-09
excluded package	package	72189-033	72189-033-60	I	Inactivated by FDA	2026-09-09
excluded package	package	72189-033	72189-033-90	I	Inactivated by FDA	2026-09-09

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 2 · 62 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72189-033-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72189-033-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72189-033-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72189-033-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-033-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-033-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-033-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-033-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-033-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-033-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-033-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-033-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-033-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-033-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-033-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-033-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-033-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-033-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-033-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72189-033-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72189-033-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72189-033-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72189-033-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72189-033-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72189-033-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72189-033-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72189-033-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72189-033-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72189-033-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209743-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A209743-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A209743-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A209743-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A209743-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A209743-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A209743-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A209743-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A209743-001	AB
A209743-002	AB
A209743-003	AB
A209743-004	AB
A209743-005	AB
A209743-006	AB
A209743-007	AB
A209743-008	AB

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 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209743-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-008	AB	1	`fd3edfee7708…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55JG375S6M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483438	Internal RxNorm lookup
483442	Internal RxNorm lookup
483444	Internal RxNorm lookup
483446	Internal RxNorm lookup
577127	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72189-033-60	2023-01-30	C162847	48780-1	f386c649-d49f-0266-e053-dadaa90a7c1a	PREGABALIN
72189-033-90	2023-01-30	C162847	48780-1	f386c64a-3c7a-0266-e053-dadaa90a7c1a	PREGABALIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-033-30	PREGABALIN	30 in 1 BOTTLE	CAPSULE	30	13
72189-033-60	PREGABALIN	60 in 1 BOTTLE	CAPSULE	60	1
72189-033-90	PREGABALIN	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-033-30	EA - Each	72189-033	55e846f9-ec65-47ef-9a20-24269c6a546a	1	2019-10-07
72189-033-60	EA - Each	72189-033	47301aa4-77fb-44be-8774-e2e91a3fa803	1	2019-10-07
72189-033-90	EA - Each	72189-033	6902c501-94a1-4f0c-8c80-739e4278230a	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-033	PREGABALIN CAPSULE [DIRECT_RX]	13	Current NDC, Legacy NDC, 1 package rows	20250119_91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d.zip
72189-033	PREGABALIN CAPSULE [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190906_91cf34b3-d546-3110-e053-2995a90a5788.zip
72189-033	PREGABALIN CAPSULE [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190906_91cf4a51-18aa-06a6-e053-2995a90a93bd.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	d095accf-9cea-4948-b43d-ae1b8fbce7c2	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3d9d7123-5886-4b61-a7ea-471b213e77d9	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3099759f-cb24-40e8-b482-9388c38c73b9	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
PREGABALIN	PREGABALIN	Direct_Rx	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743 ndc (product): 72189-033
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89ca3-5597-1c75-e053-2a95a90a3ff2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	af739a0d-a3cd-754f-e053-2a95a90ad655	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b8172d6b-a646-e559-e053-2a95a90ac24d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	bc1b143d-feaf-9498-e053-2995a90acf50	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b817083c-b535-2269-e053-2a95a90af5b9	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Proficient Rx LP	a17f03ea-9375-48fe-be32-f8df509f5fba	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
55JG375S6M	PREGABALIN	148553-50-8	PREGABALIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483438	pregabalin 100 MG Oral Capsule	PSN	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483446	pregabalin 200 MG Oral Capsule	PSN	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
577127	pregabalin 225 MG Oral Capsule	PSN	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483442	pregabalin 25 MG Oral Capsule	PSN	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483444	pregabalin 300 MG Oral Capsule	PSN	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483438	pregabalin 100 MG Oral Capsule	SCD	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483446	pregabalin 200 MG Oral Capsule	SCD	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
577127	pregabalin 225 MG Oral Capsule	SCD	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483442	pregabalin 25 MG Oral Capsule	SCD	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483444	pregabalin 300 MG Oral Capsule	SCD	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	13
483438	pregabalin 100 MG Oral Capsule	PSN	91cf34b3-d546-3110-e053-2995a90a5788	1
483438	pregabalin 100 MG Oral Capsule	PSN	91cf4a51-18aa-06a6-e053-2995a90a93bd	1
483438	pregabalin 100 MG Oral Capsule	SCD	91cf34b3-d546-3110-e053-2995a90a5788	1
483438	pregabalin 100 MG Oral Capsule	SCD	91cf4a51-18aa-06a6-e053-2995a90a93bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-033-30	72189003330	30 CAPSULE in 1 BOTTLE (72189-033-30)	30 capsule	2019-09-05	0000-00-00	No	No	Current
72189-033-60	72189003360	60 CAPSULE in 1 BOTTLE (72189-033-60)	60 capsule	2019-09-05	0000-00-00	No	No	Current
72189-033-90	72189003390	90 CAPSULE in 1 BOTTLE (72189-033-90)	90 capsule	2019-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREGABALIN	Direct_Rx	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	13
PREGABALIN	Direct_Rx	2019-09-05	HUMAN PRESCRIPTION DRUG LABEL	1
PREGABALIN	Direct_Rx	2019-09-05	HUMAN PRESCRIPTION DRUG LABEL	1