erythromycin

Product NDC
72162-2075
11-digit product format
721622075
Labeler code
72162
Product ID
72162-2075_4ddb7356-308f-4c0a-bda1-7c49fb7efe29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA063038
Marketing category
ANDA
Marketing start
2011-12-19
Substance
ERYTHROMYCIN
Active strength
20 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A063038-001ERYTHROMYCINERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A063038-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-113f01610625f2…
2019-09-15 20:21 UTC2019-09A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063038-001ERYTHROMYCIN2%SOLUTION / TOPICALATRS1991-01-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A063038-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063038-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A063038-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063038-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063038-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063038-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063038-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063038-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063038-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063038-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063038-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063038-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063038-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063038-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063038-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063038-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063038-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063038-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063038-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063038-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063038-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A063038-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063038-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063038-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063038-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A063038-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063038-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063038-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063038-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063038-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063038-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063038-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063038-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063038-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A063038-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A063038-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063038-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063038-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063038-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063038-001AT1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63937KV33DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
318202Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00c4f27e-59e2-4173-99b1-59dd295e83deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2075-6erythromycin1 in 1 CARTONSOLUTION1101
72162-2075-6erythromycin60 mL in 1 BOTTLESOLUTION60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2075-6ML - Milliliter72162-207507ea85b1-b0b6-461e-ae8a-2d8fd8c105b112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2075ERYTHROMYCIN SOLUTION [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20241013_00c4f27e-59e2-4173-99b1-59dd295e83de.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
erythromycinERYTHROMYCINBryant Ranch Prepack00c4f27e-59e2-4173-99b1-59dd295e83de2024-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063038
application number: ANDA063038
ndc (product): 72162-2075
erythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.8349b4ec-3ca6-bdb6-e053-2a91aa0a8b632024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063038
application number: ANDA063038
erythromycinERYTHROMYCINPadagis Israel Pharmaceuticals Ltd40edf1bd-42bb-4662-aff6-01fcc133c05d2022-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063038
application number: ANDA063038

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318202erythromycin 2 % Topical SolutionPSN00c4f27e-59e2-4173-99b1-59dd295e83de101
318202erythromycin 20 MG/ML Topical SolutionSCD00c4f27e-59e2-4173-99b1-59dd295e83de101
318202erythromycin 2 % Topical SolutionSY00c4f27e-59e2-4173-99b1-59dd295e83de101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2075-6721622075061 BOTTLE in 1 CARTON (72162-2075-6) / 60 mL in 1 BOTTLE1 bottle2023-08-16NoNoCurrent