IBUPROFEN

Product NDC: 12634-682
11-digit product format: 126340682
Labeler code: 12634
Product ID: 12634-682_36fc14a6-4944-4e90-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA075682
Marketing category: ANDA
Marketing start: 2008-11-20
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 800 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 29 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-682		I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-00	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-01	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-09	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-40	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-42	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-50	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-52	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-54	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-57	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-59	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-60	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-61	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-63	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-66	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-67	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-69	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-71	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-74	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-78	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-79	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-80	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-81	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-82	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-85	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-91	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-94	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-95	I	Inactivated by FDA	2026-08-03
excluded package	package	12634-682	12634-682-96	I	Inactivated by FDA	2026-08-03

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 11 · 609 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-682-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-682-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-682-57	`2ef7874e63bc…`	`57b86245f4fa…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075682-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14
A075682-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14
A075682-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075682-001	AB
A075682-002	AB
A075682-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-682-00	IBUPROFEN	10 in 1 BOTTLE	TABLET	10	7
12634-682-01	IBUPROFEN	100 in 1 BOTTLE	TABLET	100	7
12634-682-09	IBUPROFEN	35 in 1 BOTTLE	TABLET	35	7
12634-682-40	IBUPROFEN	40 in 1 BOTTLE	TABLET	40	7
12634-682-42	IBUPROFEN	42 in 1 BOTTLE	TABLET	42	7
12634-682-50	IBUPROFEN	50 in 1 BOTTLE	TABLET	50	7
12634-682-52	IBUPROFEN	12 in 1 BLISTER PACK	TABLET	12	7
12634-682-54	IBUPROFEN	14 in 1 BLISTER PACK	TABLET	14	7
12634-682-57	IBUPROFEN	20 in 1 BLISTER PACK	TABLET	20	7
12634-682-59	IBUPROFEN	30 in 1 BLISTER PACK	TABLET	30	7
12634-682-60	IBUPROFEN	60 in 1 BOTTLE	TABLET	60	7
12634-682-61	IBUPROFEN	10 in 1 BLISTER PACK	TABLET	10	7
12634-682-63	IBUPROFEN	3 in 1 BLISTER PACK	TABLET	3	7
12634-682-66	IBUPROFEN	6 in 1 BLISTER PACK	TABLET	6	7
12634-682-67	IBUPROFEN	7 in 1 BLISTER PACK	TABLET	7	7
12634-682-69	IBUPROFEN	9 in 1 BLISTER PACK	TABLET	9	7
12634-682-71	IBUPROFEN	30 in 1 BOTTLE	TABLET	30	7
12634-682-74	IBUPROFEN	24 in 1 BOTTLE	TABLET	24	7
12634-682-78	IBUPROFEN	28 in 1 BOTTLE	TABLET	28	7
12634-682-79	IBUPROFEN	25 in 1 BOTTLE	TABLET	25	7
12634-682-80	IBUPROFEN	20 in 1 BOTTLE	TABLET	20	7
12634-682-81	IBUPROFEN	21 in 1 BOTTLE	TABLET	21	7
12634-682-82	IBUPROFEN	12 in 1 BOTTLE	TABLET	12	7
12634-682-85	IBUPROFEN	15 in 1 BOTTLE	TABLET	15	7
12634-682-91	IBUPROFEN	1 in 1 BLISTER PACK	TABLET	1	7
12634-682-94	IBUPROFEN	4 in 1 BOTTLE	TABLET	4	7
12634-682-95	IBUPROFEN	5 in 1 BOTTLE	TABLET	5	7
12634-682-96	IBUPROFEN	6 in 1 BOTTLE	TABLET	6	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12634-682-60	EA - Each	12634-682	83bb0c69-1222-445b-bf15-c44a604c84b8	1	2015-02-02
12634-682-71	EA - Each	12634-682	d4ce125f-441c-4b87-af24-f8f63d3a2c9b	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [APOTHECA, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [APOTHECA, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [APOTHECA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [APOTHECA, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [APOTHECA, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [APOTHECA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [APOTHECA, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [APOTHECA, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [APOTHECA, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [APOTHECA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [APOTHECA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-682	IBUPROFEN TABLET [APOTHECA INC.]	7	Legacy NDC, 28 package rows	20160706_0396bfec-afe1-460c-8141-e8ad877b4bc0.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals, Inc.	72ec2491-924d-460f-9510-62d624d54b59	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Golden State Medical Supply, Inc.	bbf4821d-f9fc-9f6e-e053-2a95a90a5253	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522b794-5c93-44cd-e063-6394a90ab39a	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	45223597-0ea8-b275-e063-6394a90a8412	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522cb9e-4999-c455-e063-6294a90a294f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Proficient Rx LP	a7098fa1-b5ae-485e-ada9-64154f81fb6a	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Golden State Medical Supply, Inc.	3ff501eb-5ae3-8824-e063-6394a90ac58e	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	ba86e936-ef72-43e5-aebf-f2c788fe2266	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	8ea0e303-3967-4d71-8255-ac42a841ce28	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Dr. Reddy's Laboratories Limited	24731405-219c-79b4-ecf0-7d5fbfda94ba	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBU	RedPharm Drug, Inc.	4db219dc-ea48-490c-e054-00144ff88e88	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6005b-492e-7936-e063-6394a90ad801	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6ac7a-fa3e-4dd4-e063-6294a90a29af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7650f84b-92f2-4065-8ef2-f5de5bd7002b	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	593d9870-0213-75e6-e053-2991aa0a0eff	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals Inc.	575c275c-3e1a-0572-e053-2991aa0adabd	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	678e2d16-33f3-67a7-e053-2991aa0a1132	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Proficient Rx LP	ea6f626d-cda3-46e2-9ac9-4e72204cb726	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	b0f03994-b744-4d66-95b7-8c86217882bc	2021-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd	2021-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197806	ibuprofen 600 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197807	ibuprofen 800 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197805	ibuprofen 400 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197806	ibuprofen 600 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197807	ibuprofen 800 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-682-00	12634068200	10 in 1 BOTTLE	Historical
12634-682-01	12634068201	100 in 1 BOTTLE	Historical
12634-682-09	12634068209	35 in 1 BOTTLE	Historical
12634-682-40	12634068240	40 in 1 BOTTLE	Historical
12634-682-42	12634068242	42 in 1 BOTTLE	Historical
12634-682-50	12634068250	50 in 1 BOTTLE	Historical
12634-682-52	12634068252	12 in 1 BLISTER PACK	Historical
12634-682-54	12634068254	14 in 1 BLISTER PACK	Historical
12634-682-57	12634068257	20 in 1 BLISTER PACK	Historical
12634-682-59	12634068259	30 in 1 BLISTER PACK	Historical
12634-682-60	12634068260	60 in 1 BOTTLE	Historical
12634-682-61	12634068261	10 in 1 BLISTER PACK	Historical
12634-682-63	12634068263	3 in 1 BLISTER PACK	Historical
12634-682-66	12634068266	6 in 1 BLISTER PACK	Historical
12634-682-67	12634068267	7 in 1 BLISTER PACK	Historical
12634-682-69	12634068269	9 in 1 BLISTER PACK	Historical
12634-682-71	12634068271	30 in 1 BOTTLE	Historical
12634-682-74	12634068274	24 in 1 BOTTLE	Historical
12634-682-78	12634068278	28 in 1 BOTTLE	Historical
12634-682-79	12634068279	25 in 1 BOTTLE	Historical
12634-682-80	12634068280	20 in 1 BOTTLE	Historical
12634-682-81	12634068281	21 in 1 BOTTLE	Historical
12634-682-82	12634068282	12 in 1 BOTTLE	Historical
12634-682-85	12634068285	15 in 1 BOTTLE	Historical
12634-682-91	12634068291	1 in 1 BLISTER PACK	Historical
12634-682-94	12634068294	4 in 1 BOTTLE	Historical
12634-682-95	12634068295	5 in 1 BOTTLE	Historical
12634-682-96	12634068296	6 in 1 BOTTLE	Historical