Suppliers and packagers for ACULAR LS

ACULAR LS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA	Allergan, Inc.	0023-9277-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER	2003-08-19
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-3550-0	1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER	2013-11-21
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-773-05	1 BOTTLE, DROPPER in 1 CARTON (60758-773-05) / 5 mL in 1 BOTTLE, DROPPER	2013-11-21

Suppliers and packagers for ACULAR LS

Last updated: May 25, 2026

ACULAR LS suppliers: who manufactures and supplies acular LS (ketorolac tromethamine ophthalmic solution, preservative-free) and what to check in sourcing and FDA listings

Executive summary: ACULAR LS (ketorolac tromethamine) ophthalmic solution is supplied through specific branded-and-generic manufacturing supply chains tied to the FDA drug product listing and the Orange Book reference listed drug (RLD) status. To identify the actual “suppliers” (listed manufacturers, labelers, and contract manufacturers) you must map ACULAR LS’s labeler/manufacturer on the FDA label and the Orange Book listing to any site-specific drug substance and drug product manufacturing. Without those ACULAR LS-specific FDA listing identifiers, an accurate supplier roster cannot be produced.

Which companies supply ACULAR LS ketorolac ophthalmic solution?

ACULAR LS is marketed as a ketorolac tromethamine ophthalmic solution. “Suppliers” in pharma sourcing typically means one or more of the following, each of which is captured differently in FDA systems:

• Labeler/Applicant (the entity shown on the US label and typically on Drug Registration and Listing)
• Manufacturer/packager listed on the FDA label (including site-specific manufacturing)
• Contract manufacturing organizations (CMOs) for drug product and, in some cases, drug substance
• Distribution partners (often distinct from manufacturing)

What to check for ACULAR LS (to get the actual supplier list):

• The most recent FDA-approved label for ACULAR LS, under “Manufactured for” / “Distributed by”
• FDA Drugs@FDA product listing for ACULAR LS, including applicants and labeler identity
• FDA Drug Registration and Listing (DRLS) and the structured listing record for the product
• Orange Book listing for the RLD to identify the labeler tied to the reference
• If relevant, FDA inspection history and site listings that correspond to the label’s manufacturer

What is the Orange Book status of ACULAR LS ketorolac ophthalmic solution?

Featured-snippet answer: Orange Book status tells you whether ACULAR LS has an identified reference listed drug (RLD) and whether listed patents cover the formulation, method of use, or manufacturing process for the product.

How to use Orange Book for sourcing decisions:

• The RLD ties to a specific labeler/applicant record.
• Patent-listed products often map to a specific drug product site that manufactures the commercial dosage form.
• Changes in manufacturing sites can appear as supplement changes without altering the RLD listing, so the labeler and manufacturer names must still be verified against the current label.

What patents protect ACULAR LS and do they affect supplier selection?

Where this matters for “suppliers”:

• If patents remain in force (formulation, process, or method-of-use), the competitive universe of manufacturers for AB/generic or authorized supply may be constrained by licensing or design-around requirements.
• Even for branded supply, ongoing patent protection can influence who is willing to manufacture under contract at scale if there is litigation risk.

A sourcing-grade patent mapping requires the exact Orange Book listing for ACULAR LS and its listed patents (numbers, assignees, expiration dates). Without the ACULAR LS patent list, no accurate protection/constraint analysis can be generated.

When does ACULAR LS lose exclusivity, and what generic entry risks exist?

Generic entry risks depend on:

• Patent expiration (including listed patents and any pediatric exclusivity)
• Any 180-day exclusivity triggered by a first Paragraph IV filer
• 505(j) ANDA status and any listed therapeutic equivalence determinations
• Possible manufacturing site exclusivity via process patent coverage

A correct exclusivity timeline requires product-specific Orange Book data for ACULAR LS (patent and exclusivity end dates tied to the RLD).

Which dosage forms and strengths are covered for ACULAR LS ketorolac?

ACULAR LS is a ketorolac ophthalmic solution (the “LS” designation is commonly used for formulation/delivery characteristics, often tied to lower viscosity or optimized formulation). Supplier mapping depends on whether you are sourcing:

• a specific strength (mg/mL)
• a specific pack type (unit-dose vs bottle, preservative system)
• labeling (preservative-free vs preserved, depending on the product format)

Without the exact NDC(s) and the current label’s description for ACULAR LS, suppliers cannot be deterministically identified.

Which manufacturing sites make ACULAR LS drug product?

To list actual manufacturing sites, the process is:

1. Pull the current FDA label for ACULAR LS.
2. Extract the labeled manufacturer, packager, and distributor names and addresses.
3. Cross-check with DRLS for site-level registration tied to the product’s NDC.
4. For “true suppliers,” map any additional manufacturing described in label sections like “Manufactured for.”

A supplier list that includes names without label- or NDC-grade verification risks being incorrect.

How do you map ACULAR LS suppliers to FDA NDC and labeler records?

A sourcing workflow that produces a high-confidence supplier roster:

• Use ACULAR LS’s exact NDC as the anchor.
• Extract labeler/applicant and manufacturer/packager from the FDA label.
• Verify site-level registration on DRLS.
• Confirm that the Orange Book RLD entry corresponds to the same labeler/applicant record.

This approach yields the “who supplies” list that is usable for procurement, qualification, and regulatory documentation.

Commercial landscape: are there multiple ACULAR LS suppliers or only one?

The branded ophthalmic market frequently uses:

• one primary branded product manufacturer,
• possible secondary CMOs for packaging or scale,
• and distinct distributors.

Whether ACULAR LS is produced by one site or multiple sites must be confirmed from the current label and site registrations tied to the product NDC.

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Key Takeaways

• “Suppliers for ACULAR LS” must be derived from FDA labeler/manufacturer and DRLS records tied to the product’s exact NDC and Orange Book/RLD listing.
• A supplier roster cannot be accurately stated without the ACULAR LS-specific FDA listing identifiers (labeler/manufacturer names from the current label and NDC-linked DRLS entries).
• Patent and exclusivity timelines can constrain entry and affect who can supply, but they also require ACULAR LS Orange Book patent data to quantify.

FAQs

1. How can procurement teams identify the contract manufacturer for ACULAR LS?
   By extracting “Manufactured for” and “Manufactured by” from the current FDA label and validating the site in DRLS against the ACULAR LS NDC.

2. Is ACULAR LS considered an RLD in the Orange Book?
   Confirm by locating ACULAR LS’s Orange Book entry and checking whether it is listed as an RLD and which patents are attached.

3. Do packaging changes (unit-dose vs bottle) change the supplier list for ACULAR LS?
   They can. Packaging configuration often maps to different packager sites, so supplier names can vary by NDC.

4. Can a generic supplier manufacture ACULAR LS if patents expire but exclusivity remains?
   Only after the applicable patent and exclusivity periods tied to the Orange Book listing lapse for the specific RLD.

5. What documentation is typically required to qualify a new ACULAR LS supplier?
   FDA label-aligned manufacturing site registration evidence, batch release/COA history, and conformity with the applicable NDC-specific product description.

References

1. FDA. Drugs@FDA. Product label and applicant/manufacturer information for ACULAR LS (ketorolac tromethamine ophthalmic solution).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. ACULAR LS listing and patent linkages.
3. FDA. Drug Registration and Listing (DRLS). Site registration records for the ACULAR LS NDC(s).