NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product NDC: 50090-0247
11-digit product format: 500900247
Labeler code: 50090
Product ID: 50090-0247_2df71383-cdc7-4f27-bf66-4cd1cef9f8a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin sulfate, polymyxin b sulfate and gramicidin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA064047
Marketing category: ANDA
Marketing start: 1996-01-31
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN
Active strength: 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064047-001	AT

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 · 43 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
2026-09-14 22:38:34	2026-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A064047-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064047-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064047-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064047-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064047-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064047-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064047-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064047-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064047-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064047-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064047-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064047-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064047-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064047-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064047-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064047-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064047-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064047-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064047-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064047-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064047-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064047-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064047-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064047-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064047-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064047-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064047-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064047-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064047-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064047-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064047-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064047-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064047-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064047-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064047-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064047-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064047-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064047-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064047-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064047-001	AT	1	`f41ea6bd6efb…`

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: NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	1.75 mg/mL
POLYMYXIN B SULFATE	10000 [USP'U]/mL
GRAMICIDIN	.025 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup
5IE62321P4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310594	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9691178e-5323-40ce-a8b3-f79e88f02797	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0247-0	2023-02-07	C162847	48780-1	f386c649-a206-0266-e053-dadaa90a7c1a	Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP
50090-0247-0	2023-01-30	C162847	48780-1	f386c649-a206-0266-e053-dadaa90a7c1a	Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0247-0	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	1 in 1 CARTON	SOLUTION/ DROPS	1		20
50090-0247-0	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0247-0	ML - Milliliter	50090-0247	9d6acf78-e858-4fab-ba17-a6c659d8d648	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0247	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	18	Current NDC, Legacy NDC, 2 package rows	20230208_9691178e-5323-40ce-a8b3-f79e88f02797.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	A-S Medication Solutions	9691178e-5323-40ce-a8b3-f79e88f02797	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064047 application number: ANDA064047 ndc (product): 50090-0247
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	Bausch & Lomb Incorporated	e6f8d2f6-adff-4ae1-982c-45562f0a8e28	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064047 application number: ANDA064047

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
5IE62321P4	GRAMICIDIN	1405-97-6	GRAMICIDIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310594	gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic Solution	PSN	9691178e-5323-40ce-a8b3-f79e88f02797	20
310594	gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Solution	SCD	9691178e-5323-40ce-a8b3-f79e88f02797	20
310594	gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic Solution	SY	9691178e-5323-40ce-a8b3-f79e88f02797	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0247-0	50090024700	1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP	A-S Medication Solutions	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	20