FDA.reportPublic FDA data

Acetaminophen, Ibuprofen

Product NDC
72657-157
Requested package NDC
72657-157-05
11-digit product format
726570157
Labeler code
72657
Product ID
72657-157_b3d8d869-735e-4720-8b2b-a3eacc92041f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA218311
Marketing category
ANDA
Marketing start
2024-05-07
Substance
IBUPROFEN; ACETAMINOPHEN
Active strength
125; 250 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218311-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218311-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-04-26a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218311-001PC2024-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218311-001PC2024-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218311-001PC2024-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218311-001PC2024-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218311-001PC2024-11-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218311-001PC2024-11-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218311-001PC2024-11-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218311-001PC2024-11-031e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen, Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN125 mg/1
ACETAMINOPHEN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387532Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57a8dc2b-a3bc-49fa-b605-2330155bdbffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72657-157-05Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-05Acetaminophen, Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
72657-157-18Acetaminophen, Ibuprofen18 in 1 BOTTLETABLET, FILM COATED183
72657-157-18Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-20Acetaminophen, Ibuprofen250 in 1 BOTTLETABLET, FILM COATED2503
72657-157-20Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-36Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-36Acetaminophen, Ibuprofen36 in 1 BOTTLETABLET, FILM COATED363
72657-157-72Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-72Acetaminophen, Ibuprofen72 in 1 BOTTLETABLET, FILM COATED723
72657-157-74Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
72657-157-74Acetaminophen, Ibuprofen144 in 1 BOTTLETABLET, FILM COATED1443
72657-157-76Acetaminophen, Ibuprofen216 in 1 BOTTLETABLET, FILM COATED2163
72657-157-76Acetaminophen, Ibuprofen1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-157-74EA - Each72657-157ff1edcd2-0736-4b55-baa3-bda5d290b57b12026-03-17
72657-157-76EA - Each72657-1575c9e6b9d-5635-4e0f-9362-30ec8fcc119612026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-157ACETAMINOPHEN, IBUPROFEN TABLET, FILM COATED [GLENMARK THERAPEUTICS INC., USA]2Current NDC, 14 package rows20240509_57a8dc2b-a3bc-49fa-b605-2330155bdbff.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, IbuprofenACETAMINOPHEN, IBUPROFENGLENMARK THERAPEUTICS INC., USA57a8dc2b-a3bc-49fa-b605-2330155bdbff2025-07-31WarningsExact identifier
application applno (ANDA): 218311
application number: ANDA218311
ndc (package): 72657-157-05
ndc (product): 72657-157
ndc11 (package): 72657015705

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN57a8dc2b-a3bc-49fa-b605-2330155bdbff3
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD57a8dc2b-a3bc-49fa-b605-2330155bdbff3
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY57a8dc2b-a3bc-49fa-b605-2330155bdbff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-157-05726570157051 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoCurrent