FDA.reportPublic FDA data

Saxagliptin and Metformin Hydrochloride

Product NDC
43598-620
11-digit product format
435980620
Labeler code
43598
Product ID
43598-620_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Saxagliptin and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA207678
Marketing category
ANDA
Marketing start
2023-08-09
Substance
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
Active strength
500; 5 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09
A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09
A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207678-001AB
A207678-002AB
A207678-003AB

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 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-002METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-003METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALABRS2023-08-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207678-001METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207678-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207678-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207678-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207678-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207678-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207678-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207678-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207678-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207678-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207678-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207678-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207678-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207678-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207678-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207678-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207678-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207678-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207678-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207678-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207678-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Saxagliptin and Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAXAGLIPTIN500 mg/1
METFORMIN HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9GB927LAJWInternal UNII lookup
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043563Internal RxNorm lookup
1043570Internal RxNorm lookup
1043578Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65884427-4dde-63bb-a23f-36a7779c0a6bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
f5a91c01-b85a-4a74-4259-0bddd9950e83Product name220240828
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-620-30Saxagliptin and Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-620-30EA - Each43598-6205474ebc1-f6b1-4b89-b1ca-5fef1067d4ea12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-620SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]6Current NDC, 1 package rows20250122_65884427-4dde-63bb-a23f-36a7779c0a6b.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
Saxagliptin and Metformin HydrochlorideSAXAGLIPTIN AND METFORMIN HYDROCHLORIDEDr.Reddys Laboratories Inc65884427-4dde-63bb-a23f-36a7779c0a6b2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207678
application number: ANDA207678
ndc (product): 43598-620

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043563sAXagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN65884427-4dde-63bb-a23f-36a7779c0a6b7
1043570sAXagliptin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN65884427-4dde-63bb-a23f-36a7779c0a6b7
1043578sAXagliptin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN65884427-4dde-63bb-a23f-36a7779c0a6b7
104356324 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral TabletSCD65884427-4dde-63bb-a23f-36a7779c0a6b7
104357024 HR metformin hydrochloride 1000 MG / saxagliptin 5 MG Extended Release Oral TabletSCD65884427-4dde-63bb-a23f-36a7779c0a6b7
104357824 HR metformin hydrochloride 500 MG / saxagliptin 5 MG Extended Release Oral TabletSCD65884427-4dde-63bb-a23f-36a7779c0a6b7
1043563metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral TabletSY65884427-4dde-63bb-a23f-36a7779c0a6b7
1043570metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 5 MG 24 HR Extended Release Oral TabletSY65884427-4dde-63bb-a23f-36a7779c0a6b7
1043578metformin hydrochloride 500 MG / saxagliptin (as saxagliptin hydrochloride) 5 MG 24 HR Extended Release Oral TabletSY65884427-4dde-63bb-a23f-36a7779c0a6b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-620-304359806203030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30) 2023-08-09NoNoCurrent