FDA.reportPublic FDA data

Acetaminophen, Ibuprofen

Product NDC
72657-157
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
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

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

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 bottle2024-05-07NoNoHistorical
72657-157-18726570157181 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical
72657-157-20726570157201 BOTTLE in 1 CARTON (72657-157-20) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical
72657-157-36726570157361 BOTTLE in 1 CARTON (72657-157-36) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical
72657-157-72726570157721 BOTTLE in 1 CARTON (72657-157-72) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical
72657-157-74726570157741 BOTTLE in 1 CARTON (72657-157-74) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical
72657-157-76726570157761 BOTTLE in 1 CARTON (72657-157-76) / 216 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-07NoNoHistorical