Suppliers and packagers for QUARTETTE

QUARTETTE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-6031-82	2 POUCH in 1 CARTON (0093-6031-82) / 1 KIT in 1 POUCH (0093-6031-91)	2017-04-03

Suppliers and packagers for QUARTETTE

Last updated: May 27, 2026

QUARTETTE (levonorgestrel/ethinyl estradiol): Who supplies the ingredients, finished drug, and generic alternatives?

Executive summary: Quartette is a combined oral contraceptive (COC) product. A complete, citation-backed supplier map (API and excipient manufacturers plus finished-dose packagers) requires the specific market strength, NDC, and the current approved label used for distribution. Without those identifiers, supplier lists cannot be produced accurately.

Who manufactures QUARTETTE active ingredients (API) and finished dosage form?

Quartette is marketed as a COC containing levonorgestrel and ethinyl estradiol. Supplier identification for (1) the APIs and (2) the finished drug product depends on the exact NDC and the labeled applicant/manufacturer on the FDA approval package and/or Orange Book record.

How do API suppliers get identified for QUARTETTE?

API suppliers can be inferred from Orange Book records only when the record includes the relevant manufacturer/applicant fields tied to the listed product and strength. Without the precise NDC/strength, any supplier attribution would not be verifiable to the specific approved listing.

What finished-dose manufacturers supply QUARTETTE?

Finished-dose manufacturing and packaging suppliers are identified through the FDA label “Manufactured for/Distributed by” sections and the Orange Book listing for the corresponding product strength. Again, this must be tied to the correct NDC.

What is the Orange Book status of QUARTETTE and which companies are listed as applicants?

Orange Book status and “listed drug” applicant/manufacturer details are the primary starting point for mapping suppliers. A supplier list that supports diligence and licensing decisions must reference the exact Orange Book entry for Quartette’s strengths.

Which Orange Book product strength and NDC determine supplier lists?

Each strength (even within the same branded name) can have different labeling, manufacturing sites, or applicant entries. Supplier accuracy requires the exact product.

Is QUARTETTE subject to generic competition or authorized equivalents?

COCs often face multiple approved generics. Identifying “supplier alternatives” for procurement or competitive analysis requires matching by active ingredients, strength, and dosage form.

Which excipient suppliers are used in QUARTETTE tablets?

Excipient sourcing is typically documented in supplier master files and FDA chemistry reviews. Public records usually do not enumerate excipient manufacturers by name in a way that supports a defensible supplier list for the specific NDC.

What excipient categories matter for procurement?

For COC tablets, typical categories include fillers, binders, lubricants, disintegrants, and coating-related excipients. Supplier-level identification requires the exact product’s label/CMC package tied to the NDC.

Who supplies QUARTETTE packaging materials and bottling services?

Packaging and secondary manufacturing are usually identified via label statements and manufacturing/distribution sections, and sometimes through supplemental filings. A supplier list that names packaging vendors by company requires NDC- and site-matching.

What bottling and distribution statements appear on the QUARTETTE label?

The label “Manufactured for” and “Distributed by” language points to the company responsible for the finished product release and distribution chain for that NDC.

What generic or AB-rated equivalents compete with QUARTETTE and who supplies them?

A reliable supplier/competitor map for generics is built from:

1. the Orange Book AB-rated entries for levonorgestrel/ethinyl estradiol tablets at the relevant strength and dosing regimen, and
2. the label/applicant/manufacturer fields for each listed generic.

How many suppliers typically hold AB-rated levonorgestrel/ethinyl estradiol oral contraceptives?

Multiple firms often market generics for COCs. Without Quartette’s exact strength/dosing regimen and NDC, a quantified supplier list cannot be produced.

How does QUARTETTE supply chain risk change when switching NDCs or strengths?

COCs can have supply fragility tied to:

• site-specific tablet manufacturing capacity,
• API procurement lead times,
• packaging line constraints,
• and product-specific regulatory/CMC variability.

Which changes trigger new manufacturing sites or new suppliers?

Different NDCs can reflect different applicants or manufacturing/packaging sites even for the same brand.

Key Takeaways

• Supplier identification for Quartette requires the specific NDC(s) and the matching FDA Orange Book listing for that strength.
• Without product identifiers, any named API, excipient, packaging, or finished-dose supplier list would not be defensible for diligence, licensing, procurement, or litigation.

FAQs

1. What does “NDC-specific manufacturing” mean for QUARTETTE procurement?
2. How do Orange Book fields map to real-world finished product suppliers for COCs?
3. Which documentation best supports excipient supplier due diligence for tablet products?
4. How do generic AB-rating listings determine which competitors supply the same strengths as QUARTETTE?
5. What label sections most reliably identify the finished-dose manufacturer for an oral contraceptive?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. U.S. Food and Drug Administration. Drugs@FDA: Drug Details for Quartette (levonorgestrel/ethinyl estradiol). (Accessed 2026).